ANALGESICS LABELLING STANDARD

DESCRIPTION:

Single Entity and Multiple Entity Drugs containing analgesic ingredients for OTC use as analgesics.

MEDICINAL INGREDIENTS: All finished product and ingredients used in the manufacture of the product should comply with the specifications of Schedule B pharmacopoeial or equivalent standard. The medicinal ingredients of a product complying with this standard consist of the following ingredients when used singly or in acceptable combinations within the established limits given: (1) Acetaminophen (2) Salicylates: - Acetylsalicylic Acid - Sodium Salicylate - Magnesium Salicylate - Choline Salicylate (3) Ibuprofen (4) Codeine, if: - Not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form - Not more than 20 mg or its equivalent of codeine phosphate per 30 ml in a liquid preparation, if the preparation contains, - two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half the regular minimum single dose for each such ingredient, or - three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient. (Section 36(1) of the Narcotic Control Regulations).

revised: 94-12-02

PERMITTED COMBINATIONS: - Salicylates or Acetaminophen with Caffeine - Salicylates and Buffering Agents Unacceptable Combinations - combination of two different salicylates (C.09.010) - combination of acetaminophen with a salicylate (C.09.010) - combination of acetaminophen or salicylates with herbal ingredients (I.L. 659) ADEQUATE DIRECTIONS FOR USE: Indications: Acceptable claims: - to relieve fever - to relieve pain due to arthritis, or rheumatism - analgesic, to relieve minor aches and pain - to relieve the pain of menstrual cramps - to relieve the pain of dental work or intervention, toothache - to relieve headache - to relieve the pain due to muscle sprains and strains - buffered (see salicylates)

Unacceptable claims: (except if in professional literature, eg. prescribing information available on request to physicians and pharmacists) - anti-inflammatory, to relieve inflammation - arthritis, rheumatism - dysmenorrhea - rheumatic fever - prevent blood clot or any mention of anti-platelet action - neuralgia NOTE: This labelling standard describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use should also be met. REFERENCES: - Food and Drugs Act and Regulations - Information Letter No. 659, February 29, 1984 - Information Letter No. 743, April 15, 1988 - Canadian Self-Medication, 3rd edition 1988 Product Regulation Division Bureau of Nonprescription Drugs

revised: 94-12-02

ACETAMINOPHEN

DESCRIPTION: A drug that contains acetaminophen as a single medicinal ingredient, or acetaminophen in combination with caffeine. (C.09.021(1)) Pharmaceutical forms: tablets, capsules, suppositories, effervescent tablets, liquid, syrup, elixir, drops, granules, caplets MEDICINAL INGREDIENTS AND CONCENTRATIONS: 325 mg, 500 mg per dosage unit- adults 80 mg, 160 mg per dosage unit - children PERMITTED COMBINATIONS: see introduction

ADEQUATE DIRECTIONS FOR USE: Indications: as for all classes (see Analgesic Labelling Standard Introduction) Dosage Directions: (ORAL) (a) ADULTS AND CHILDREN 12 YRS AND OVER: Maximum Single dose: 650 mg (2 X 325 mg) Maximum Daily dose : 4.0 g (12 X 325 mg) Interval : recommended every 4 hours. (b) CHILDREN UNDER 12 YRS: C.01.024 Age years 11-12 9-10 6-8 4-5 2-3 months 12-23 4-11 0-3 mg 480 400 320 240 160 120 80 40 Single Dose X 80 mg 6 5 4 3 2 X 160 mg 3 2 2 1 1 X 325 mg 1 1 1 mg 2400 2000 1600 1200 800 Daily Dose X 80 mg 30 25 20 15 10 7 5 2 X 160 mg 15 12 10 7 5

1 600 1 400 200 Interval : recommended every 4 hours.

Dosage Directions: (RECTAL) The recommended single and daily dosages above may be increased to 331/3 per cent in excess of the above oral doses. (C.01.022(b))

(c) LIQUID PREPARATIONS: (i) Products Recommended Solely for Children To be taken as drops (C.09.022(4),(5)) shall contain either of the children's standard dosage units per millilitre An accurate measuring device shall be provided and must be capable of accurately delivering 0.5 millilitres of the product NOT to be taken as drops (C.09.022(6)) shall contain either of the children's standard dosage units per teaspoon

(ii) Adults: shall contain one adult standard dosage unit per teaspoon.(C.09.022(7))

Warnings: (i) to consult a physician if the underlying condition requires continued use for more than five days(C.09.011(a)) that it is hazardous to exceed the maximum recommended dose unless advised by a physician (C.09.011(b)) keep out of the reach of children (C.01.029(1)) that there is enough drug in the package to seriously harm a child, if greater than 3.2 g of acetaminophen in package (C.01.029(2c)) (iii) and (iv) must be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour (C.01.029(3)) at least one of the package sizes available for sale must be provided in a child resistant package and the outer label of all containers that are not child resistant shall carry a statement that the drug is also available in a child resistant package.(C.01.031(a)(ii),(b))

(ii)

(iii) (iv)

(v)

(vi)

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(vii)

Information within adequate directions for use concerning significant incompatibilities and drug interactions, significant side effects, and information on the emergency management of overdose, must be included in the labelling material (see appendix II). If the package label does not have sufficient space, the above information may be included on a package insert provided the label instructs the consumer to consult it. (I.L. 659)

NOTE: Items (i) and (ii) apply to all products containing acetaminophen, including cough and cold products. Items (iii - vi) do not apply if the product is in effervescent, suppository or powder form; or packaged in a non-reclosable package containing not more than two adult standard dosage units per package (C.01.031.2(c),(d),(f))

- Adults Only products: (i) that this product is not a standard dosage unit product, if an acetaminophen product in the form of a tablet, capsule or other solid dosage form contains 500 mg of acetaminophen per individual dosage form (C.09.022(2)). that product be used only on the advice of a physician, for products containing more than two or three times the adult standard dosage unit per dosage form, or for products that recommend dosages in excess of 650 mg per single dose, and/or 4g per day. (C.01.025)

(ii)

- Children Only products: (i) that the drug be used as directed by a physician OR that the maximum doses of the drug not exceed the above dosage instructions and that single doses not be administered more frequently than every four hours. (C.01.024(3)(a),(b)) (ii) that the drug be packaged in a child resistant container (C.01.031(a)(i)) the package shall contain no more than 1.92g in the 80 mg dosage units (or 3.2 g in the 160 mg dosage units). (C.01.037(c)(d))

(iii)

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- Codeine-containing preparations (i) The following warning must appear conspicuously on the main panel of the label: "This preparation contains codeine and should not be administered to children except on the advice of a physician or a dentist." (ii) The formulation (or list of ingredients) of the product must appear conspicuously on the main panel of the label. The inner and outer labels shall show on the upper left quarter of the main panel of the label, the symbol "N" in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used thereon.

(iii)

Package Insert

If package labels do not have sufficient space to carry all of the above information, the information within adequate directions for use (see (vii) above), and the detailed dosage schedule may be included on a package insert, provided the package label instructs the consumer to read the package insert for further information.

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SALICYLATES DESCRIPTION: A drug that contains a salicylate as a single medicinal ingredient, in combination with caffeine, in combination with one or more buffering agents or antacids or in combination with caffeine and one or more buffering agents or antacids. (C.09.031(1)) Pharmaceutical forms (ASA): tablets, sustained release tablets, enteric coated tablets, effervescent tablets, powder, gum, capsules, suppositories, caplets

MEDICINAL INGREDIENTS AND CONCENTRATIONS: (Standard dosage units) Adult - Acetylsalicylic Acid 325 mg, 500 mg 80 mg - Sodium Salicylate 325 mg, 500 mg - Magnesium Salicylate 325 mg, 500 mg - Choline Salicylate 435 mg PERMITTED COMBINATIONS: A salicylate as a single medicinal ingredient, in combination with; - caffeine, - one or more buffering agents or antacids, - caffeine and one or more buffering agents or antacids. Buffered Salicylate Products: The term "buffered" is acceptable for salicylate products that provide at least 1.9 mEq of acid neutralizing capacity for 325 mg of ASA or equivalent.(C.09.034) ADEQUATE DIRECTIONS FOR USE: Indications : Adults and children 12 years and over: as for all classes (see Analgesic Labelling standard Introduction) Children under 12 years: limited to the relief of pain. Dosage Directions: (ORAL) Acetylsalicylic Acid Magnesium Salicylate Sodium Salicylate Children 80 mg 80 mg 110 mg

a) ADULTS AND CHILDREN 12 YRS AND OVER : maximum single dose: 650 mg (2 X 325 mg) maximum daily dose : 4.0 g (12 X 325 mg) revised: 94-12-02 7

interval: recommended every 4 hours

b) CHILDREN UNDER 12 YRS: Age years 11-12 9-10 6-8 4-5 2-3 under 2* mg 480 400 320 240 160 Single Dose X 80 mg 6 5 4 3 2 X 325 mg 1 1 1 Daily Dose mg 2400 2000 1600 1200 800 X 80 mg 30 25 20 15 10

Interval : recommended every 4 hours. * as directed by a physician

Dosage Directions: Choline Salicylate (ORAL) a) ADULTS AND CHILDREN 12YRS AND OVER: maximum single dose: 870 mg (2 X 435 mg) maximum daily dose : 5.22 g (12 X 435 mg) interval : recommended every 4 hours b) CHILDREN UNDER 12 YRS: Age years 11-12 9-10 6-8 4-5 2-3 under 2* mg 660 550 440 330 220 Single Dose X 110 mg 6 5 4 3 2 X 435 mg 1 1 1 mg 3300 2750 2200 1650 1100 Daily Dose X 110 mg 30 25 20 15 10 X 435 mg 7 6a 5 3 2

Interval : recommended every 4 hours. * as directed by a physician

revised: 94-12-02

Dosage Directions: The recommended single and daily dosages (RECTAL) above may be increased to 331/3 per cent in excess of the above oral doses. (C.01.022(b)) (c) LIQUID PREPARATIONS: (i) Adults: The product shall contain one adult standard dosage unit per teaspoon. (C.09.033(1))

Warnings: (i) to consult a physician if the underlying condition requires continued use for more than five days(C.09.011(a)) that it is hazardous to exceed the maximum recommended dose unless advised by a physician (C.09.011(b)) keep out of the reach of children (C.01.029(1)) that there is enough drug in the package to seriously harm a child, if greater than 1.5g of salicylic acid, 2g of acetylsalicylic acid, or their equivalent in package (C.01.029(2a,b)) (iii) and (iv) must be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour (C.01.029(3)) at least one of the package sizes available for sale must be provided in a child resistant package. The outer label of all containers that are not child resistant shall carry a statement that the drug is also available in a child resistant package.(C.01.031(a)(ii),(b)) that products containing acetylsalicylic acid should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye Syndrome, a rare serious illness, (C.01.028 (1)(e))

(ii)

(iii) (iv)

(v)

(vi)

(vii)

(viii) Information within adequate directions for use concerning significant incompatibilities and drug interactions, significant side effects, and information on the emergency management of overdose, must be included in the labelling material (see appendix III). If the package label does not have sufficient space, the above information may be included on a package insert provided the label instructs the consumer to consult it. (I.L. 659) revised: 94-12-02 9

NOTE: Items (i) and (ii) apply to all products containing salicylic acid or a salt or derivative, including cough and cold products. items (iii - vi) do not apply if the product is in effervescent, suppository or powder form; or packaged in a non-reclosable package containing not more than two adult standard dosage units per package (C.01.031.2(c),(d),(f)) Item (vii) the regulation does not require specific wording; Internationally acceptable wording that complies with the intent of this regulation is permitted.

- Adults Only products: (i) To consult a physician before taking the drug during the last three months of pregnancy or when nursing. (C.09.012) Regulations require this statement on all salicylates for internal use, however, it has been determined that this caution would not be suitable for products recommended solely for children. (ii) The label must state that the product is not a standard dosage unit if the product is in the form of a tablet, capsule or other solid dosage form intended for oral administration and contains 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate or 670 mg of choline salicylate (C.09.032(2)(a) & (b)) The label must state that each individual dosage form contains two or three adult standard dosage units; if the product is in the form of a tablet, capsule or other solid dosage form intended for oral administration and contains two or three adult standard dosage units of a salicylate per individual dosage form (C.09.032(3)(a)(b)) The label must state that each teaspoon of the product contains two or three adult standard dosage units if the product is in the form of a liquid and contains two or three adult standard dosage units of a salicylate per teaspoon (C.09.033(2)(a)(b)) for products that recommend dosages in excess of 650 mg per single dose, and/or 4g per day, a statement that they be used only on the advice of a physician.(C.01.025)

(iii)

(iv)

(v)

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- Children Only products: (i) that the drug be used as directed by a physician or that the maximum doses of the drug not exceed the above dosage instructions and that single doses not be administered more frequently than every four hours. (C.01.024(3)(a) &(b)) (ii) that the drug be packaged in a child resistant container (C.01.031(a)(i)) the package shall contain no more than 1.92g (C.01. 037(c)( d))

(iii)

- Codeine-containing preparations: (i) The following warning must appear conspicuously on the main panel of the label: "This preparation contains codeine and should not be administered to children except on the advice of a physician or a dentist." (ii) The formulation (or list of ingredients) of the product must appear conspicuously on the main panel of the label. The inner and outer labels shall show on the upper left quarter of the main panel of the label, the symbol "N" in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used thereon.

(iii)

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IBUPROFEN DESCRIPTION: Pharmaceutical forms: tablets, capsules

MEDICINAL INGREDIENTS AND CONCENTRATION: Ibuprofen: 200 mg per dosage unit PERMITTED COMBINATIONS:

ADEQUATE DIRECTIONS FOR USE: Indications: For the temporary relief of: - menstrual pain (dysmenorrhea) - toothache (dental pain) - minor aches and pains in muscles, bones and joints - fever, headache - pain due to arthritis or rheumatism Dosage Directions: - Adults and children 12 years of age and over: 200-400 mg every 4 hours - Maximum daily dose of 1200 mg, except as directed by a physician. Warnings: - Consult a physician if the underlying condition requires continued use for more than five days. -Information within adequate directions for use concerning significant incompatibilities and drug interactions, side effects, and information on the emergency management of overdose, must be included in the labelling material (see appendix IV). If the package label does not have sufficient space, the above information may be included on a package insert provided the label instructs the consumer to consult it.

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+)))))))))))))))))))))))))))))))))))))0)))))))))0)))))))0))))))), * APPENDIX I: * U.S.P. * B.P. * B.P.C.* * FORMULATED PREPARATIONS * XXII * 1988 * 1976 * * * (1990) * * * /)))))))))))))))))))))))))))))))))))))3)))))))))3)))))))3)))))))1 * X * * * * Acetaminophen Capsules * Acetaminophen Oral Solution * X * * * * Acetaminophen Oral Solution, * * X* * * Pediatric * * * * * * Acetaminophen for Effervescent * X * * * Oral Solution * * * * * * Acetaminophen Oral Suspension * X * X * * * Acetaminophen Tablets * X * X * * * X * * * * Acetaminophen and Acetylsali* cylic Acid Tablets * * * * * X * * * * Acetaminophen, Acetylsali* cylic Acid and Caffeine Capsules* * * * * Acetaminophen, Acetylsali* X * * * * cylic Acid, and Caffeine Tablets* * * * * X * * * * Acetaminophen and Codeine * Phosphate Capsules * * * * * Acetaminophen and Codeine * X * * * Phosphate Elixir * * * * * * Acetaminophen and Codeine * X * * * Phosphate Tablets * * * * * * Acetaminophen and Diphenhydramine * X * * * * Citrate Tablets * * * * * X * * * * Acetylsalicylic Acid Capsules * Acetylsalicylic Acid Delayed* X * * * * release Capsules * * * * * Acetylsalicylic Acid Suppositories * X * * * * X * X * * * Acetylsalicylic Acid Tablets * Acetylsalicylic Acid Tablets for * * * * * Oral Solution * * * * * Acetylsalicylic Acid Extended* X * * * * release Tablets * * * * * Acetylsalicylic Acid, Alumina and * X * * * * Magnesia Tablets * * * * * Acetylsalicylic Acid and Caffeine * * X * * * Tablets * * * * * Acetylsalicylic Acid and Codeine * X * * * * Phosphate Tablets * * * * * Acetylsalicylic Acid, Codeine Phos- * X * * * * phate, Alumina,and Magnesia * * * * * Tablets * * * * * Acetylsalicylic Acid, Codeine Phos- * X * * * * phate, and Caffeine Capsules * * * * * Acetylsalicylic Acid, Codeine Phos- * X * * * * phate, and Caffeine Tablets * * * * * Dispersible Acetylsalicylic Acid * * X * * * Tablets * * * * .)))))))))))))))))))))))))))))))))))))2)))))))))2)))))))2)))))))-

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+)))))))))))))))))))))))))))))))))))))0)))))))))0)))))))0))))))), * APPENDIX I: * U.S.P. * B.P. * B.P.C.* * FORMULATED PREPARATIONS * XXII * 1988 * 1976 * * * (1990) * * * /)))))))))))))))))))))))))))))))))))))3)))))))))3)))))))3)))))))1 * X * X * * * Ibuprofen Tablets * Soluble Acetylsalicylic Acid Tablets* * X** * * * Soluble Acetylsalicylic Acid Tablets* * * X * Pediatric * * * * * .)))))))))))))))))))))))))))))))))))))2)))))))))2)))))))2)))))))-

* - Elixir or Mixture may be used in place of Oral Solution **- Effervescent may be used in place of Soluble

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APPENDIX II ACETAMINOPHEN SUPPLEMENTARY INFORMATION RE: ADEQUATE DIRECTIONS FOR USE

i) Significant Incompatibilities and Drug Interactions

A physician or pharmacist should be consulted prior to taking this medication in case of: - allergy to acetaminophen, chronic alcoholism, serious kidney or liver disease - intake of other medications containing acetaminophen and salicylates

ii) Side-Effects

- allergic reaction such as rash or itching

iii) Information on the Emergency Management of Overdose If poisoning occurs, call a Poison Control Centre or doctor immediately, even if there are no symptoms.

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APPENDIX III SALICYLATES SUPPLEMENTARY INFORMATION RE: ADEQUATE DIRECTIONS FOR USE

i)

Significant Incompatibilities and Drug Interactions A physician or pharmacist should be consulted prior to taking this medication in case of: - allergy to salicylates, asthma, pregnancy and breast-feeding - stomach problems, peptic ulcer, severe liver disease, or gout - history of blood coagulation defects, or receiving anticoagulant drugs, or five to seven days prior to surgery, or with severe anaemia - intake of other medications containing salicylates, or acetaminophen, anti-inflammatory drugs, anticonvulsants, anti-diabetic or gout medicine

ii) Side-Effects A physician should be contacted if any of the following reactions develop during treatment: - bleeding or irritation of stomach, nausea, vomiting, pain - any loss of hearing, including ringing or buzzing in the ears - skin rashes, hives or itching - breathing difficulties

Side-Effects for Buffered Salicylates A physician should be contacted if any of the following reactions develop during treatment: - skin rashes, hives or itching - breathing difficulties In addition, individuals with a history of stomach problems, kidney or liver disease should consult a physician if any of the following reactions develop during treatment: - bleeding or irritation of stomach, nausea, vomiting, pain - any loss of hearing, including ringing or buzzing in the ears

iii) Information on the Emergency Management of Overdose * If poisoning occurs, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.

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APPENDIX IV IBUPROFEN Supplementary information RE: Adequate Directions for Use: i) Significant incompatibilities and Drug Interactions - Do not take this product if you are allergic to products containing acetylsalicylic acid (ASA), other salicylates or other anti-inflammatory drugs. - Consult your physician or pharmacist before taking this product if you have peptic ulcers, high blood pressure, heart failure, kidney or liver disease, any other serious disease, pregnancy or nursing or are taking any other drug. - Do not take this product while taking acetylsalicylic acid (ASA).

ii) Side Effects A physician should be contacted if any of the following reactions develop during treatment: - abdominal pain, heartburn, nausea or vomiting, bloating, diarrhea or constipation - ringing or buzzing in the ears, dizziness or any change in vision - fluid retention, itching, skin rashes. iii) Information on the Emergency Management of Overdose If poisoning occurs, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.

revised: 94-12-02

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