Antacid

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Labelling Standard

Category: Antacid

Description: Single and multiple ingredient drugs, containing medicinal ingredients suitable for self-medication, which are intended to relieve symptoms such as heartburn and dyspepsia, traditionally associated with gastric hyperacidity.

Medicinal Ingredients and Dosage Forms:

Dosage forms covered by this standard: gel, powder, suspension, liquid, tablets, effervescent tablets

The finished product and all ingredients used in the manufacture of the product should comply with the specifications of Schedule B pharmacopoeial or equivalent standard (Appendix I).

The medicinal ingredients of a product complying with this monograph consist of the following when used singly, within the established limits or in an acceptable combination.

Ingredients (Single or Combination):

1. aluminum containing:

   aluminum hydroxide **
   dihydroxyaluminum aminoacetate (aluminum glycinate)
   dihydroxyaluminum sodium carbonate

2. magnesium-containing:

   magnesium carbonate
   magnesium hydroxide
   magnesium oxide
   magaldrate*

3. calcium carbonate
   
   
4. sodium bicarbonate

Note:

* contains magnesium and aluminum

** The declaration of aluminum hydroxide should be made using the proper name of the ingredient used (eg. Dried Aluminum Hyroxide Gel) but giving the equivalent weight of aluminum hydroxide (mol.wt. 78).

For example:

Dried Aluminum Hydroxide gel equivalent to x mg aluminum hydroxide

(where 1 mg dried gel provides 0.765 mg aluminum hydroxide)

or

Aluminum Hydroxide Gel equivalent to x mg aluminum hydroxide

(where 100g aluminum hydroxide gel USP provides 5.5 - 6.7 g aluminum hydroxide)

Permitted Combinations:

1. Antacid Ingredient Combinations:

Any of the antacid ingredients listed above (a-d) may be combined with each other or with those ingredients listed below (e and f), provided each contributes at least 25% of the acid neutralising capacity (ANC) as calculated by the following formula:

% contribution = (Total mEq antacid active ingredient × 100) ÷ (Total mEq antacid product)

• magnesium trisilicate
• glycine

2. Antacid and Non-antacid Combinations:

The following non-antacid ingredients (g and h) will be permitted in combination with any acceptable single or combination ingredient listed above provided the indication statement refers to their action (see indications permitted):

• alginic acid / alginates
• simethicone

Note: combination of antacid with an analgesic ingredient is not included in this labelling standard

Directions for use:

Indications:

1. For antacid ingredients, to the effect:

For the relief of heartburn, (indigestion), (upset stomach), (sour stomach) associated with excess stomach acid (hyperacidity), (acid indigestion)

Alternative acceptable claims are as follows:

• antacid
• neutralizes excess stomach acid

Note: Any reference to the following claims is unacceptable in antacid products:

• reflux esophagitis
• hiatus hernia
• gastric or intestinal ulcers
• consumes "x" times its weight in stomach acid

2. For combination ingredients:

1. Alginic acid/Alginates, to the effect:
   • for the relief of heartburn due to backward flow of stomach acid
   • stomach acid reflux
2. Simethicone, to the effect:
   • antiflatulent
   • relieves gas due to heartburn, indigestion, sour or upset stomach

3. For calcium carbonate: *

• calcium/mineral supplement

4. For magnesium (carbonate, hydroxide or oxide): *

• magnesium/mineral supplement

* a mineral supplement claim may be made in addition to an antacid claim provided that:

1. the product contains one or more of these 4 salts as the only medicinal ingredient(s)
   
   
2. the amount of the elemental mineral (calcium or magnesium) per dosage unit is declared
   
   
3. separate dosage directions that conform with the Minerals Labelling Standard are also given

Dosage:

1. Antacid ingredients:

• The minimum recommended dosage must provide a minimum acid neutralising capacity (ANC) of 5 mEq and result in a pH of 3.5 or greater at the end of the initial ten minute period as measured by the procedure outllined in the United States Pharamacopeia XXII/National Formulary XVII. Evidence that a product meets this standard must be available on request.
  
  
• The maximum daily dose of acceptable ingredients should not exceed the following levels:
  
  
  • Aluminum hydroxide 10000 mg
  • Dihydroxyaluminum aminoacetate 4000 mg
  • Dihydroxyaluminum sodium carbonate 8016 mg
  • Magnesium carbonate 3288 mg
  • Magnesium hydroxide 7200 mg
  • Magnesium oxide 1920 mg
  • Magaldrate 10800 mg
  • Calcium carbonate 8000 mg
  • Sodium bicarbonate 6000 mg
  • Magnesium trisilicate 4680 mg
  • Glycine 8000 mg

2. Combination non-antacid ingredients:

The maximum daily dose should not provide more than the following levels

• Alginic acid 4000 mg
• Simethicone 640 mg

3. Dosage as an antacid should be specified as being for adults

4. Dosages for mineral supplementation (where applicable) should not exceed those given in the Mineral Supplement Labelling Standard:

• for calcium, up to a maximum of 1500 mg per day
• for magnesium, up to a maximum of 500 mg per day

Warnings:

For all ingredients:

1. Do not take for more than two weeks, or if symptoms recur, unless directed by a doctor
2. Do not take within two hours of another medicine because the effectiveness of the other medicine may be altered.

For products containing magnesium or aluminum:

1. Individuals with kidney disease should not take this product except on the advice of a doctor

For products with more than 115 mg sodium in daily dose:

1. Do not use if you are pregnant or on a low salt diet

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:

1. Gilman, A. and L.S. Goodman, The Pharmacological Basis of Therapeutics, 8th Ed., Pergamon Press, Chapt. 42, pp. 980-993, 1990.
2. American Pharmaceutical Association, Handbook of Nonprescription Drugs, 9th Ed., Chapt.11, pp. 243-292, 1990.
3. The Medical Letter on Drugs and Therapeutics, vol.33, pp 111-114, November 29,1991
4. American Medical Association, Drug Evaluations Annual 1992, Chapt. 43 pp. 818-841, 1992.
5. Harrison's Principles of Internal Medicine, 12th Edition, Chapt. 43, pp 251-256 and 1234-1248, 1991
6. Canadian Pharmaceutical Association, Self-Medication: A Reference for Health Professionals, Chapt. 15, pp. 245-253, 1992
7. Department of Health and Human Services, Food and Drug Administration, Federal Register, Antacids for Over-the Counter Human Use, Final Order, Vol 39, No.108, pp. 19862-19877, 1974
8. United States Pharmacopeial Convention, Drug Information for the Health Professional, Vol. 1B, United States Pharmacopeial Convention, Inc., pp. 272-306, 1989.
9. Department of Health and Human Services, Food and Drug Administration, Federal Register, Proposed Establishment of Monographs for OTC Antacid Products, vol. 38, No. 65, pp. 8714-8724, 1973
10. American Hospital Formulary Service, Drug Information, American Society of Hospital Pharmacists, Inc., pp. 1490-1491 and 1706-1711, 1992.
11. Gennaro, A.R. (Ed.), Remington's Pharmaceutical Sciences, 17th Ed.. Mack Publishing Co., 1985.
12. The United States Pharmaopoeia, 12th Ed., 1990
13. Hem.S.L., Journal of Chemical Education, vol.52, No.6, pp. 383-385, June 1975
14. Hem.,S.L, White,J.L.,Buehler, J.D.,Luber, J.R.,Grim.,W.M.,and Lipka.E,A., American Journal of Hospital Pharmacy, vol. 39, pp 1925-1930, 1982
15. Canadian Drug Identification Code Book, 1992
16. The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, 10th Ed., 1983.
17. Reynolds, J.E.F. (Ed.), Martindale: The Extra Pharmacopoeia 29th Ed., The Pharmaceutical Press, 1989.
18. United States Pharmacopeial Convention, Advice for the Patient - Drug Information in Lay Language, Vol. II, United States Pharmacopeial Convention, Inc., pp. 715-724, 1989.
19. Department of Health and Human Services, Food and Drug Administration, Federal Register, Establishment of a Monograph for Orally Administered Products for Relief of Symptoms Associated with Overindulgence in Alcohol and Food.vol.47, No.191, pp. 43558-43559,October 1,1982
20. Department of Health and Human Services, Food and Drug Administration, Federal Register, Antacid Drug Products for OTC Human Use; Final Justification of Category III Antacid Ingredients and labelling Claims, vol. 52, N0. 172, pp. 33576-33577, 1987
21. Department of Health and Human Services, Food and Drug Administration, Federal Register, Antacid Drug products Over-the Counter Human Use; Ammendment of a Monograph, vol. 47, No.169, pp. 38480-38484, 1982
22. Department of Health and Human Services, Food and Drug Administration, Federal Register, Antiflatulent Products for Over-the -Counter Human Use, Vol 39, No.108, pp. 19877, 1974
23. Departmant of Health and Human Services, Food and Drug Administration, Federal Register, Antidiarrheal Drug Poducts for Over-the Counter Products for Human Use:Tentative Final Monograph; Proposed Rulemaking, Vol 51, No.83, pp.16138-16149, 1986
24. The Pink Sheet, F-D-C Reports, vol 53, No. 30, July 29, 1991
25. Department of National Health and Welfare of Canada, Health Protection Branch, Information Letter No. 622, Regulatory proposals Regarding Non-prescription Analgesics, May 5, 1982.
26. Department of Health and Human Services, Food and Drug Administration, Federal Register, Antacid Drug Products Over-the Counter Human Use; Proposed Amendment of a Monograph, vol. 58, No. 183, pp. 49826-49828, 1993
27. Department of Health and Human Services, Food and Drug Administration, Federal Register, Antacid Drug Products Over-the Counter Human Use; Amendment of a Antacid Final Monograph, vol. 58, No. 168, pp. 45204-45208, 1993

Appendix I Formulated Preparations

	U.S.P.XXII (1990)	B.P. 1993	B.P.C. 1976
Alumina and Magnesia Oral    Suspension	X
Alumina and Magnesia Tablets	X
Alumina, Magnesia and Calcium    Carbonate Oral Suspension	X
Alumina, Magnesia and Calcium    Carbonate Tablets	X
Alumina, Magnesia and    Simethicone Oral Suspension	X
Alumina, Magnesia and    Simethicone Tablets	X
Alumina and Magnesium Carbonate    Oral Suspension	X
Alumina and Magnesium Carbonate    Tablets	X
Alumina, Magnesium Carbonate,    and Magnesium Oxide Tablets	X
Alumina and Magnesium Trisilicate    Oral Suspension	X
Alumina and Magnesium Trisilicate    Tablets	X
Basic Aluminum Carbonate Gel	X
Dried Basic Aluminum Carbonate    Gel Capsules	X
Dried Basic Aluminum Carbonate    Gel Tablets	X
Aluminum Hydroxide Gel	X
Dried Aluminum Hydroxide Gel	X
Dried Aluminum Hydroxide Gel    Capsules	X
Dried Aluminum Hydroxide Gel    Tablets	X
Aluminum Hydroxide Tablets		X
Calcium Carbonate Oral Suspension	X
Calcium Carbonate Powder,  Compound			X
Calcium Carbonate Tablets	X
Calcium Carbonate and Magnesia    Tablets	X
Calcium and Magnesium Carbonates    Tablets	X
Dihydroxyaluminum Aminoacetate    Capsules	X
Aluminum Glycinate		X
Dihydroxyaluminum Aminoacetate    Magma	X
Dihydroxyaluminum Aminoacetate    Tablets	X
Dihydroxyaluminum Sodium    Carbonate Tablets	X
Magaldrate Oral Suspension	X
Magaldrate Tablets	X
Magaldrate and Simethicone Oral    Suspension	X
Magaldrate and Simethicone Tablets	X
Milk of Magnesia	X
Magnesia Tablets	X
Magnesia and Alumina Oral    Suspension	X
Magnesia and Alumina Tablets	X
Magnesium Carbonate Mixture			X
Aromatic Magnesium Carbonate    Mixture		X	X
Magnesium Carbonate Powder, Compound	X		X
Magnesium Carbonate Tablets,    Compound			X
Magnesium Carbonate and Sodium    Bicarbonate for Oral Suspension
Magnesium Hydroxide Mixture		X♥
Magnesium Hydroxide Paste	X
Magnesium Oxide Capsules
Magnesium Oxide Tablets
Magnesium Trisilicate Mixture	X	X♦	X
Magnesium Trisilicate Tablets	X
Compound Magnesium Trisilicate    (Oral) Powder		X	X
Compound Magnesium Trisilicate Tablets		X♣	X♣
Sodium Bicarbonate Oral Powder	X
Sodium Bicarbonate Tablets	X
Compound Sodium Bicarbonate Tablets		X♠

Alternates:
☺Oral Suspension; Mixture
☻Oral Suspension
♥Oral Suspension; Cream of Magnesia
♦Oral Suspension; Compound Magnesium Trisilicate Mixture
♣Aluminum Hydroxide and Magnesium Trisilicate Tablets
♠Soda Mint Tablets