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Name:Adult Glycerin Laxative
Manufacturer:Qualitest Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ADULT GLYCERIN LAXATIVE  - glycerin suppository 
Qualitest Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

Glycerin, USP 80.7%

PURPOSE

Laxative

USE

For relief of occasional constipation

WARNINGS

For rectal use only. May cause rectal discomfort or a burning sensation.

Do not use

  • more than one per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if seal under product lid is damaged, missing or broken.

Ask a doctor before use

  • if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby




Stop use and ask a doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.



Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • Adults and children 6 years of age and older: carefully insert one suppository well into the rectum
  • Do not use more than once per day
  • Generally produces a bowel movement in 15 minutes to 1 hour
  • Children under 6 years of age: ask a doctor.


OTHER INFORMATION

  • Store container tightly closed
  • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).

INACTIVE INGREDIENTS

sodium stearate, purified water


PACKAGE LABEL - 100 COUNT REPRESENTATIVE LABEL

NDC 0603-0511-21

GLYCERIN
SUPPOSITORIES

LAXATIVE

ADULT

100 SUPPOSITORIES


Made in the
USA
for Qualitest Pharmaceuticals, Inc.
Huntsville, AL 35811

USE ONLY IF PRINTED
FOIL SEAL IS NOT
BROKEN OR MISSING


label


ADULT GLYCERIN LAXATIVE 
glycerin suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0511
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glycerin (glycerin) glycerin 1.614 g
Inactive Ingredients
Ingredient Name Strength
sodium stearate  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-0511-35 25 SUPPOSITORY ( SUPPOSITORY) in 1 JAR None
2 NDC:0603-0511-19 50 SUPPOSITORY ( SUPPOSITORY) in 1 JAR None
3 NDC:0603-0511-21 100 SUPPOSITORY ( SUPPOSITORY) in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part334 11/28/2005 11/30/2011

Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 02/2010 Qualitest Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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