GLYCERIN- glycerin suppository

Glycerin by

Drug Labeling and Warnings

Glycerin by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc., DSC Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each suppository)

Glycerin 1.2 g

Purpose

Laxative

Uses

• for relief of occasional constipation
• this product generally produces a bowel movement in 1/4 to 1 hour
  

Warnings

For rectal use only

May cause rectal discomfort or a burning sensation

Ask a Doctor before using any laxative if child has

• abdominal pain, nausea or vomiting
• a sudden change in bowel habits lasting more than 2 weeks
• already used a laxative for more than 1 week
  

Stop use and consult a doctor if child has

• rectal bleeding
• no bowel movement within 1 hour of using this product

These symptoms 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

Single daily dosage

childrien 2 to under 6-1 suppository, or as directed by a doctor

children under 2 years-ask a doctor

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Other information

• Store container tightly closed.
• Keep away from excessive heat.
  

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Pediatric Glycerin Suppositories, 25 count

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

PediatricGlycerin Suppositories, 25 count

Distributed by C.D.M.A. Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

QC Pediatric25ct.jpg

INGREDIENTS AND APPEARANCE

GLYCERIN  
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-282
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-282-25	25 in 1 JAR; Type 0: Not a Combination Product	03/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/20/2012

Labeler - Chain Drug Marketing Association Inc. (011920774)

Registrant - DSC Laboratories Inc. (097807374)

Establishment
Name	Address	ID/FEI	Business Operations
DSC Laboratories Inc.		097807374	manufacture(63868-282)