Appropriate-Use Information and Product Labeling

Which of the following statements about the order in which entries are made in the package insert of an over-the-counter medicine is correct?

1. Following the date of revision, the entries are made in the order of the matters concerning the requirement to read and matters on storage of the package insert, then the brand name, drug efficacy classification name, and risk classification.
2. The consumer consultation contact desk is stated after the name and address of the manufacturing and marketing business operator.
3. Matters that lead to disease prevention or symptom improvement (so-called "health maintenance advice") are required to be stated in every package insert.
4. The efficacy or effect is stated after the method and dosage of use.

Which of the following statements about revision of the package insert is correct?

1. When an important content change is made, the date of revision must be stated and the revised portion clearly indicated.
2. The package insert is required to be revised periodically at least every five years.
3. Revision is limited to cases based on new knowledge concerning a pharmaceutical's efficacy, and revision based on knowledge concerning safety is not carried out.
4. The content of an over-the-counter medicine's package insert is never changed from what it was at the time of approval.

Which of the following statements about the matters concerning the requirement to read and storage of the package insert is correct?

1. The package insert only needs to be read by the purchaser who directly received information from a professional at the time of sale, and a family member or the like who actually uses the pharmaceutical need not look at it again.
2. The package insert is sufficient if looked at once when opened, regardless of who actually uses it or the person's condition at that time.
3. When a person who has used an over-the-counter medicine visits a medical institution, it is considered important to bring that package insert and show it to the physician or pharmacist for consultation.
4. Wording such as "Be sure to read this instruction document before use" is stated not above the brand name of the package insert, but at the very end of the package insert.

Which of the following statements about the "brand name, drug efficacy classification name, and risk classification" and "product features" of the package insert is correct?

1. The product features are stated for the purpose of clearly explaining an overview of the product to the person using the pharmaceutical.
2. Even when the drug efficacy classification name is included in the brand name, the drug efficacy classification name entry cannot be omitted.
3. For a test kit not used directly on the human body, it is stated as "brand name, drug efficacy classification name, and risk classification."
4. The drug efficacy classification name refers to the approved brand name itself.

Which of the following statements about the "precautions for use" section of the package insert is correct?

1. "Other precautions" states that, for a serious side effect that rarely occurs, a physician should be consulted immediately.
2. It is composed of "Things not to do," "Consult a professional," and "Other precautions."
3. Because it is considered an item important for appropriate use, it is compiled together in the latter part of the package insert.
4. It is stated in the same typeface and size as other entries, so as not to be distinguished from them.

Which of the following statements about the "efficacy or effect" and "method and dosage of use" sections of the package insert is correct?

1. The method and dosage of use is stated with devices such as a table format, showing age category, dose per use, and number of uses per day, among other matters.
2. Even when there is an age category not approved for use in children, that fact is not stated.
3. Precautions related to efficacy or effect are stated only in the "precautions for use" section, and are never stated immediately following the efficacy or effect entry itself.
4. For an over-the-counter test kit, efficacy or effect is stated as "method of use."

Which of the following statements about the "ingredients and amounts" section of the package insert is correct?

1. An ingredient included as an additive is not stated in the package insert.
2. Because an additive is not known to cause an allergy, there is no need to avoid use even for a person with a history of allergy.
3. The name and amount of the active ingredient is stated, and, together with that entry, an ingredient included as an additive is also listed.
4. A pharmaceutical's additive is itself included for the purpose of an active drug effect.

Which of the following statements about the "consumer consultation contact desk," "name and address of the manufacturing and marketing business operator," and other matters in the package insert is correct?

1. The field for the name and address of the manufacturing and marketing business operator states only the name and address of a sales agent or the like entrusted with sales.
2. The consumer consultation contact desk states the name and telephone number of the prefectural pharmaceutical affairs division.
3. The consumer consultation contact desk states the name, telephone number, business hours, and the like of the department at the manufacturing and marketing business operator responsible for handling consultations from purchasers and others.
4. Matters that lead to disease prevention or symptom improvement (so-called "health maintenance advice") are required to be stated in the package insert of every over-the-counter medicine.

Which of the following statements about entries in the package insert, among other documents, is correct?

1. Under the provisions of Article 52, Paragraph 2 of the Act, a designated-guidance-required pharmaceutical, an over-the-counter medicine, and a pharmacy-manufactured-and-marketed pharmaceutical are required to have entries such as "necessary precautions concerning method and dosage of use and other matters of use and handling" stated in a package insert or on its container or wrapping.
2. Package insert information for an over-the-counter medicine is not posted on the website of the Pharmaceuticals and Medical Devices Agency.
3. The precautionary information for a prescription pharmaceutical continues to be provided by inclusion of a paper package insert, not by electronic means.
4. From August 1, Reiwa 3, the inclusion of a paper package insert with an over-the-counter medicine was abolished, and precautionary information came to be provided by electronic means, but it is considered that a paper package insert will continue to be included with a prescription pharmaceutical.

Which of the following statements about "Things not to do" in the package insert is correct?

1. It states cases where, before using the pharmaceutical, its appropriateness should be discussed with a professional and an appropriate judgment made.
2. For a pharmaceutical containing an ingredient that carries a risk of a specific adverse effect in a child, it is usually stated in the "Consult a professional" section, as, for example, (a child under 15).
3. For an over-the-counter test kit, it states that, because a positive result allows a definitive diagnosis, there is no need to see a physician for a diagnosis.
4. Concomitant use with a prescription pharmaceutical is stated in the "Consult a professional" section, as, for example, "a person receiving treatment from a physician (or dentist)."

Which of the following statements about "Do not use (take) if you are one of the following people" in Appended Table 5-1 is incorrect?

1. An external analgesic/anti-inflammatory drug containing ketoprofen is instructed not to be used by a person who has previously had an allergic reaction to an analgesic/antipyretic containing tiaprofenic acid, and the reason is that it may induce contact dermatitis or photosensitivity.
2. (A person who has previously had an allergic reaction to this drug, an ingredient of this drug, or milk) is instructed not to use tannic acid albumin, and the reason is that tannic acid albumin is derived from milk casein.
3. (A person who has previously had an asthma attack) is instructed not to use an external analgesic/anti-inflammatory drug containing indomethacin, felbinac, ketoprofen, or piroxicam, and the reason is that it may induce an asthma attack.
4. "A person who has previously had an asthma attack from using (taking) this drug or another cold remedy or analgesic/antipyretic" is instructed not to use a gargle medicine containing povidone-iodine, and the reason is that it may induce aspirin-induced asthma.

In Appended Table 5-1, which of the following is an ingredient for which "a person who has previously had an asthma attack from using (taking) this drug or another cold remedy or analgesic/antipyretic" is instructed not to use it?

1. Isopropylantipyrine
2. Loperamide hydrochloride
3. Butylscopolamine bromide
4. Mequitazine

Which of the following statements about "Things not to do" concerning symptoms or conditions in Appended Table 5-1 is correct?

1. A person whose affected area is suppurating is instructed not to use an athlete's foot/ringworm medicine containing iodine tincture.
2. A person with severe abdominal pain or nausea/vomiting is instructed not to take an oral rhinitis medicine containing pseudoephedrine hydrochloride, and the reason is the possibility of acute abdomen.
3. A person with difficulty urinating due to prostatic hypertrophy is instructed not to take a laxative containing castor oil, and the reason is that it may cause urinary retention or urinary retention.
4. A person with symptoms of excess stomach acid is instructed not to take an anti-drowsiness drug whose main ingredient is caffeine, anhydrous caffeine, caffeine citrate, or another caffeine-containing ingredient.

Which of the following statements about "Things not to do" concerning an underlying condition, among other matters, in Appended Table 5-1 is incorrect?

1. A person who habitually has trouble sleeping, or has been diagnosed with insomnia, is instructed not to take a hypnotic sedative (sleep-aid medicine) whose main ingredient is an antihistamine ingredient.
2. A person diagnosed with heart disease is instructed not to use pseudoephedrine hydrochloride or shakuyakukanzoto.
3. A person undergoing dialysis treatment is instructed not to use a gastrointestinal medicine or gastrointestinal antispasmodic containing an aluminum-containing ingredient such as sucralfate, aluminum hydroxide gel, or synthetic hydrotalcite.
4. A person diagnosed with a gastric ulcer is instructed not to take loperamide hydrochloride.

Which of the following statements about age restrictions for children in Appended Table 5-1 is correct?

1. Ethyl aminobenzoate is instructed not to be used by a child under 15.
2. Castor oil preparations are instructed not to be taken by a child under 3.
3. Ibuprofen is instructed not to be taken by a child under 12.
4. Codeine phosphate hydrate is instructed not to be taken by a child under 15.

Which of the following statements about the combination of an age restriction for children and its reason in Appended Table 5-1 is correct?

1. Ingredients containing promethazine, such as promethazine hydrochloride, are instructed not to be used by a child under 15 because of a risk of causing methemoglobinemia.
2. Aspirin is instructed not to be used by a child under 15 because a link to the onset of Reye's syndrome has been suggested overseas.
3. Ethyl aminobenzoate is instructed not to be used by a child under 6 because a link to the onset of Reye's syndrome has been suggested overseas.
4. Oxethazaine is instructed not to be used by a child under 15 because of overseas reports that overdose by an infant caused paralytic ileus.

Which of the following statements about "Things not to do" concerning a pregnant woman, among others, in Appended Table 5-1 is incorrect?

1. "A pregnant woman or a woman who may be pregnant" is instructed not to take oxethazaine, and the reason is that safety during pregnancy has not been established.
2. "A pregnant woman or a woman who may be pregnant" is instructed not to take a hypnotic sedative whose main ingredient is diphenhydramine hydrochloride, and the reason is that insomnia associated with pregnancy is not a symptom indicated for a sleep-aid medicine.
3. "A pregnant woman within 12 weeks of her due date" is instructed not to take castor oil preparations.
4. "A pregnant woman or a woman who may be pregnant" is instructed not to use ethinylestradiol or estradiol, and the reason is that reports exist of congenital anomalies in the fetus arising from intake of a female hormone ingredient during pregnancy.

Which of the following is the correct combination, in Appended Table 5-1, of an ingredient for which "a breastfeeding woman should either not take this drug, or avoid breastfeeding if she does take this drug," and its reason?

1. An oral medicine containing an ingredient containing diphenhydramine, such as diphenhydramine hydrochloride — because it can cause nervous irritability in the infant
2. An antitussive/expectorant medicine containing aminophylline hydrate or theophylline — because of a risk of causing diarrhea in the infant
3. An oral medicine containing sennoside, senna, rhubarb root, or cascanthranol — because of a risk of causing coma in the infant
4. An oral medicine containing belladonna extract — because of a risk of causing tachycardia in the infant

Which of the following statements about "Do not operate a vehicle or machinery after taking this drug" in Appended Table 5-1 is correct?

1. This statement is made for an analgesic/antipyretic or hypnotic sedative containing bromovalerylurea or allylisopropylacetylurea.
2. For scopolamine hydrobromide hydrate or methyloctatropine bromide, this statement is made because they can cause drowsiness only.
3. For a gastrointestinal medicine containing pirenzepine hydrochloride hydrate, this statement is made because it can cause drowsiness.
4. This statement is not made for an antidiarrheal containing loperamide hydrochloride or belladonna extract.

Which of the following statements about the precaution concerning continuous use in Appended Table 5-1 is correct?

1. A nasal spray, regardless of ingredient, carries the instruction "do not use continuously," and the reason is that reduced sensitivity (so-called "tolerance") occurs.
2. An external hemorrhoid medicine containing a steroidal anti-inflammatory ingredient carries the instruction "limit to short-term use, and do not use continuously," and the reason is a risk of causing pseudoaldosteronism.
3. An antidiarrheal containing a bismuth-containing ingredient such as bismuth subgallate or bismuth subnitrate carries the instruction "do not take continuously for one week or more," and the reason is that reports exist, from overseas, of psychoneurotic symptoms appearing with long-term continuous use.
4. Shakuyakukanzoto carries the instruction "do not take continuously for one week or more," and the reason is that reports exist of psychoneurotic symptoms appearing.

Which of the following statements about "Consult a professional" in the package insert is correct?

1. "Consult a professional" states matters where, if not observed, symptoms will worsen, or a side effect or accident will become more likely.
2. "A person who has received the following diagnosis" is stated only for a person who is currently receiving treatment from a physician.
3. "A person with the following symptoms" states only symptoms for which using that pharmaceutical is inappropriate, and does not include a symptom that could easily be mistaken as improvable by that pharmaceutical when it in fact cannot be.
4. It is stated because, if a person receiving treatment from a physician or dentist uses a designated-guidance-required pharmaceutical or an over-the-counter medicine on their own judgment, it may interfere with the treatment, or cause overlap or interaction with an active ingredient of the same type as a prescribed drug.

Which of the following statements about "a pregnant woman or a woman who may be pregnant" in the "Consult a professional" section is correct?

1. It is often the case that safety evaluation is considered difficult because scientific data on the experience of use in pregnant women is limited.
2. For a pregnant woman, self-judged use of a pharmaceutical by an ordinary consumer, taking the effect on the fetus into account, is widely recommended.
3. Whenever this is stated, a specific adverse effect in humans has, in every case, been identified.
4. If pregnancy has already been confirmed and the woman is receiving regular obstetric checkups, there is no need to consult the attending physician.

Which of the following statements about "the elderly" as used in the precautions for use is correct?

1. As a rough guide, it refers to a person aged 75 or older.
2. In general, the elderly tend to have an increased risk of side effects with advancing age, and often have some underlying chronic condition as well.
3. Because the elderly have a high risk of side effects, they must not use a designated-guidance-required pharmaceutical or an over-the-counter medicine.
4. For anyone aged 65 or older, the degree to which risk has increased can be judged uniformly from age alone.

Which of the following statements about "a person who is breastfeeding" and "a person who has previously had an allergic reaction to a drug or the like" in the "Consult a professional" section is correct?

1. When it is known that part of an ingested pharmaceutical's ingredient transfers into breast milk, this is always stated in the "Things not to do" section.
2. A person with an allergic constitution is generally considered to have a low risk of an allergic side effect.
3. "A person who is breastfeeding" is stated here when the case is not serious enough to warrant stating, in "Things not to do," "a breastfeeding woman should either not take this drug, or avoid breastfeeding if she does take this drug."
4. "A person who has previously had an allergic reaction to a drug or the like" applies only to a person who has had an allergic reaction from using that specific pharmaceutical.

Which of the following statements about the description of side effects in the package insert is correct?

1. A symptom stated as a general side effect never includes one that could be an early symptom of a serious side effect.
2. A serious side effect is limited to health harm not severe enough to require hospitalization.
3. General side effects are first stated by affected body part, followed by symptoms of rarely occurring serious side effects, stated by name of side effect.
4. A minor symptom predictable from the pharmacological action, among other things, does not require discontinuing use even if it persists or intensifies.

Which of the following statements about the entry concerning a case where no improvement in symptoms is seen after using the pharmaceutical for a certain period or a certain number of times is correct?

1. A kampo formula preparation without a statement that a professional should be consulted for long-term continuous use is one limited to short-term use.
2. Every kampo formula preparation is considered to achieve its effect through short-term use.
3. Even if the symptom is due to a disease outside the scope of that pharmaceutical's application, there is no need to see a physician.
4. For an over-the-counter test kit, it is stated that if the test result is negative, retesting or consulting a physician is unnecessary even if some symptom is present.

Which of the following is the correct combination, in Appended Table 5-2, of an ingredient, among others, related to "a pregnant woman or a woman who may be pregnant," and its reason?

1. A cold remedy or analgesic/antipyretic containing aspirin, ibuprofen, acetaminophen, or the like — because of reports that, in experiments administering it to rats in late pregnancy, mild constriction of the fetal ductus arteriosus was observed
2. An enema or an external hemorrhoid medicine (suppository or ointment for insertion) — because it is a narcotic antitussive ingredient, and it is known that part of the absorbed ingredient crosses the blood-placental barrier and transfers to the fetus, with a risk of affecting the fetus
3. A cold remedy containing bromovalerylurea — because it is known that part of the absorbed ingredient crosses the placental barrier and transfers to the fetus
4. A vitamin A main-ingredient preparation — because of a risk of stimulating vigorous intestinal movement and inducing miscarriage or premature birth

Which of the following is the correct combination, in Appended Table 5-2, of an ingredient, among others, related to "the elderly," and its reason?

1. An enema containing glycerin — because it tends to cause pseudoaldosteronism
2. An oral medicine containing dipotassium glycyrrhizinate or licorice root — because it tends to cause worsening of glaucoma, dry mouth, difficulty urinating, or constipation as a side effect
3. An oral medicine containing an adrenergic ingredient such as methylephedrine hydrochloride or pseudoephedrine hydrochloride, or containing ephedra — because it tends to cause increased heart rate, increased blood pressure, or accelerated glucose metabolism
4. An anticholinergic ingredient such as scopolamine hydrobromide hydrate, or belladonna extract — because it tends to cause increased heart rate, increased blood pressure, or accelerated glucose metabolism

Which of the following statements about "a person who has received the following diagnosis" in Appended Table 5-2 is correct?

1. A person diagnosed with kidney disease is instructed to consult regarding diprophylline, and the reason is a risk of accumulation in the body causing aluminum encephalopathy or aluminum osteopathy.
2. A person diagnosed with a thyroid disease is instructed to consult regarding papaverine hydrochloride, and the reason is a possible increase in iodine intake into the body.
3. A person diagnosed with liver disease is instructed to consult regarding Sho-saiko-to, and the reason is a risk of worsening liver dysfunction.
4. A person diagnosed with epilepsy is instructed to consult regarding diprophylline, and the reason is that its central-nervous-system-stimulating action risks triggering an epileptic seizure.

Which of the following statements about "a person who has received the following diagnosis" and the like in Appended Table 5-2 is incorrect?

1. A person who has had a gastric or duodenal ulcer, ulcerative colitis, or Crohn's disease is instructed to consult regarding ibuprofen, and the reason is that, through its action of inhibiting prostaglandin production, the protective function of the gastrointestinal mucosa is weakened, risking recurrence.
2. A person diagnosed with systemic lupus erythematosus or mixed connective tissue disease is instructed to consult regarding ibuprofen, and the reason is that it tends to cause the side effect of aseptic meningitis.
3. A person with a blood clot (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.) is instructed to consult regarding an ingredient containing piperazine, such as piperazine phosphate, and the reason is that the existing blood clot becomes harder to break down.
4. A person diagnosed with glaucoma is instructed to consult regarding papaverine hydrochloride, and the reason is a risk that intraocular pressure will rise, worsening the glaucoma.

Which of the following statements about the distinction between "Things not to do" and "Consult a professional" is correct?

1. Use of a gastrointestinal medicine containing an aluminum-containing ingredient by a person undergoing dialysis treatment is a matter for (consult a professional).
2. A person being treated with a monoamine oxidase inhibitor (such as selegiline hydrochloride) is instructed to (consult a professional) regarding pseudoephedrine hydrochloride.
3. A person with symptoms of difficulty urinating due to prostatic hypertrophy is instructed to (consult a professional) regarding pseudoephedrine hydrochloride.
4. Use of aspirin by a child under 15 is a matter for (consult a professional).

Which of the following statements about entries on a pharmaceutical's outer box, among other places, is correct?

1. Because the package insert is normally sealed inside the outer box, part of the precautions for use is also stated on the outer box, to prevent a situation in which a purchaser or other person, after opening the product following purchase, discovers only upon reading the package insert that the product was not suitable for themselves (or a family member).
2. For a pharmaceutical with a package insert, the efficacy/effect and method/dosage of use are stated on the outer box, but the content of the precautions for use is never stated there.
3. "Do not use (take) if you are one of the following people" and "Do not use on the following body part" are never stated on the outer box, and are stated only in the package insert.
4. For some pharmaceuticals, it is permitted to state, on the outer box rather than in the form of a package insert, the entries such as "method, dosage, and other necessary precautions for use and handling" based on Article 52, Paragraph 2 of the Act, but stating the content of the precautions for use on the outer box is not permitted.

Which of the following statements about the display of a pharmaceutical's expiration date is correct?

1. For a pharmaceutical confirmed to have properties and quality that remain stable for more than three years after manufacture under appropriate storage conditions, there is no legal labeling obligation.
2. Because there is no legal obligation to display the expiration date, it is rarely stated on the outer box, among other places.
3. The displayed "expiration date" is a date up to which quality is guaranteed even after the package has been opened.
4. For a pharmaceutical sold through home delivery, the expiration date is never stated as a "delivery deadline."

Which of the following statements about matters displayed on a product, based on a law other than the Act, in addition to the legally required labeling matters under the Act, is correct?

1. The identification labeling (identification mark) on the container and packaging is based on the Fire Service Act.
2. Precautions based on the Fire Service Act or the High Pressure Gas Safety Act are required to be displayed on the container, but are never stated in the package insert.
3. The precaution "Caution: high temperature" for an aerosol product, and stating the name of the gas used, among other matters, are based on the High Pressure Gas Safety Act.
4. The precaution "Keep away from open flame," among others, for an aerosol product using a flammable gas as a propellant or for disinfectant alcohol, is based on the High Pressure Gas Safety Act.

Which of the following statements about the entry "Be sure to read the package insert before use" on the outer box, among other places, and about recommending consultation with a professional, is correct?

1. The entry "Be sure to read the package insert before use" is made so that only the pharmaceutical (including any inner bag) sealed inside the packaging is taken out, without the package insert being read.
2. Matters concerning recommending consultation with a professional are stated when the risk from a side effect is high in light of the symptoms, constitution, age, or other factors, but are not stated for a person receiving treatment from a physician or dentist.
3. Matters concerning recommending consultation with a professional are omitted when the space available for the entry is small.
4. The entry (Be sure to read the package insert before use) is made not on the outer box but only in the package insert.

Which of the following statements about entries on the outer box, among other places, is correct?

1. For an oral liquid preparation containing more than 0.1 mL of alcohol per single dose, only the fact that it contains alcohol is stated on the outer box, and it is considered that the amount is never stated either in the package insert or on the outer box.
2. While the active ingredient is stated on the outer box, an ingredient included as an additive is never stated there.
3. Matters concerning a pharmaceutical's storage are stated only in the package insert, and are never stated on its container or packaging.
4. Because some purchasers may not open the product immediately after purchase, and instead store it as is or carry it with them, precautions concerning storage are also stated on the container or packaging, so that appropriate storage is achieved even without looking at the package insert.

Which of the following statements about pharmaceutical storage conditions is correct?

1. A pharmaceutical never deteriorates or loses potency even when frozen.
2. It is considered desirable to store tablets, capsules, powders, and the like in the refrigerator, to prevent moisture.
3. Because a syrup preparation and the like readily deteriorate, it is considered desirable to store them in the refrigerator after opening.
4. To avoid accidental ingestion at home, it is important to store pharmaceuticals together with food in the same place.

Which of the following statements about "store out of reach of children" and "do not transfer to another container" is correct?

1. Even when a pharmaceutical has been transferred to a different container, as long as that container is not damp or dirty, the pharmaceutical's appropriate quality is maintained, so there is no particular problem.
2. If a pharmaceutical is transferred to a different container for carrying while traveling or to work, it can become unclear over time what the medicine was, which risks becoming a cause of misuse.
3. It is acceptable to place a pharmaceutical somewhere within a child's sight, as long as it is still out of the child's reach.
4. There has never been a reported case of accidental ingestion arising from a pharmaceutical being placed somewhere a child can easily reach (such as at a sick person's bedside), or somewhere within a child's sight even if thought to be out of reach.

Which of the following statements about "Precautions on storage and handling" is correct?

1. For eye drops, "do not share with another person" is stated because, if sharing among multiple users occurs, and the liquid happens to become bacterially contaminated during use, there is a risk of infecting another user.
2. For eye drops, "do not share with another person" is considered to be stated because sharing among multiple users would cause the liquid to run out faster, making it unavailable when needed.
3. "Precautions on storage and handling" is an item included within the "precautions for use" section of the package insert.
4. "Do not share with another person" is stated for every pharmaceutical, not only eye drops.

Which of the following statements about the use of product labeling information is correct?

1. When the content of a package insert or outer box labeling is revised, it is considered that a product reflecting the revision is immediately distributed by the manufacturing and marketing business operator and reaches purchasers, so a product with the pre-revision entry never remains on the market, and there is no risk of a purchaser encountering old, pre-revision information.
2. The content stated as "precautions for use" in the package insert can never be inferred at all from the listing of ingredients, among other entries.
3. Among risk classifications of designated-guidance-required pharmaceuticals and over-the-counter medicines, a Class 1 pharmaceutical and a Class 2 pharmaceutical are ones presenting a risk of health harm to a degree that interferes with daily life due to a side effect or the like, and it is considered significant that being classified into these risk classifications can be readily determined from the product labeling.
4. Even when an environment in which package insert information can be viewed in advance is not in place, there is no particular need to make use of the appropriate-use information readable from the outer box labeling, and it is sufficient to read the package insert after purchase.