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Drugs and Health Products

NATURAL HEALTH PRODUCT

Hyperosmotic Laxatives

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 5, 2021

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source ingredient

1,2,3-Propanetriol

  • Glycerin
  • Glycerine
  • Glycerol

Glycerol

  • D-Glucitol
  • D-Sorbitol
  • D-Glucitol
  • D-Sorbitol
  • Sorbitol

Sorbitol

1The ingredients must be pharmacopoeial grade.

References: Proper names: Gottschalck and McEwen 2006, NF 24 2006, USP 29 2006, BP 2003, O'Neil et al. 2001; Common names: Gottschalck and McEwen 2006, NF 24 2006, USP 29 2006, BP 2003, O'Neil et al. 2001; Source information: Gottschalck and McEwen 2006, NF 24 2006, USP 29 2006, BP 2003, O'Neil et al. 2001.

Route of administration

Rectal (FDA 1985)

Dosage form(s)

Suppository, Enema (FDA 1985)

Use(s) or Purpose(s)

  • For relief of occasional constipation and/or irregularity (FDA 1985)
  • Laxative (FDA 1985)
  • Promotes evacuation of the lower bowel (Sweetman).

Dose(s)

Subpopulation(s):

As specified below

Quantity(ies):

Table 2. Dose information of Glycerine and Sorbitol based on dosage forms and subpopulations
Medicinal - Ingredients Dosage form(s) Subpopulation(s) Dose/day
Minimum Maximum
Glycerine Rectal suppository Children 2-5 years 1.0 g 1.7 g
Children 6-11 years 2 g 3 g
Adolescents 12-17 years
Adults 18 years and older
Rectal enema Children 2-5 years 2 ml of 80% v/v solution 5 ml of 80% v/v solution
Children 6-11 years 5 ml of 80% v/v solution 15 ml of 80% v/v solution
Adolescents 12-17 years
Adults 18 years and older
Sorbitol Rectal enema Children 2-11 years 30 ml of 25-30% w/v solution 60 ml of 25-30% w/v solution
Adolescents 12-17 years 120 ml of 25-30% w/v solution
Adults 18 years and older

Reference: FDA 1985.

Directions for use

All products

Do not take this product within 2 hours of another medicine as the desired effect of the other medicine may be reduced (Berardi et al. 2002).

Suppositories

  • Remove suppository from wrapper (for suppositories packaged in a wrapper) (FDA 1990).
  • Gently insert into the rectum
  • Allow 15 minutes to 1 hour to produce bowel movement (FDA 1985).

Enemas

  • Lubricate anus with petroleum jelly before inserting the enema applicator (USP DI 1997).
  • Gently insert the tip of the enema applicator to prevent damage to the rectal wall (USP DI 1997).
  • Allow 15 minutes to 1 hour to produce bowel movement (FDA 1985).

Duration(s) of use

Do not use this product beyond 7 days (FDA 1985).

Risk information

Caution(s) and warning(s)

All products
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen (FDA 1990).
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician promptly in case of bleeding (FDA 1990).
Products containing glycerine

Stop use and consult a health care practitioner/health care provider/health care professional/doctor/physician if rectal discomfort or a burning sensation occurs (FDA 1985).

Contraindication(s)

All products

Do not use this product if you have abdominal pain, nausea, fever or vomiting (FDA 1985).

Products containing glycerine

Do not use this product use if you have rectal irritation (Berardi et al. 2002).

Known adverse reaction(s)

No statement required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References cited

  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • BP 2003: British Pharmacopoeia Commission. British Pharmacopoeia. London (UK): The Stationary Office; 2003.
  • FDA 1990. USA Department of Health and Human Services: Food and Drug Administration. 55 CFR Part 346. Next link will take you to another Web site Anorectal Drug Products for Over-the-Counter Human Use; Final Monograph; 1990. FR Citation: 55FR31776 [Accessed 2019 July 4]. Available at: https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-anorectal-drug-products
  • FDA 1985. USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 334. Next link will take you to another Web site Laxative Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; 1985. FR Citation: 50FR2124 [Accessed 2019 July 4]. Available at: https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-laxative-drug-products
  • NF 24: United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th edition. Whitehouse Station (NJ): Merck and Co., Inc; 2001.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference. 33rd edition. Grayslake (IL): Pharmaceutical Press; 2002.
  • USP 29: United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.
  • USP DI 1997. Advice for the Patient, Volume II, 17th edition. Rockville (MD): United States Pharmacopoeial Convention; 1996.