Active ingredient (in each suppository)

Glycerin 1 g

Purpose

Hyperosmotic 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 of burning sensation

Ask a Doctor before using laxative if child has

abdominal pain, nausea or vomiting
a sudden change in bowel habits lasting more than two 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
children 2 to under 6 years	1 suppository or as directed by a doctor
children under 2 years	ask a doctor

Insert suppository well up intorectum.

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

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

PediatricGlycerin Suppositories, 25 count

Distributed by Pharmacy Value Alliance, LLC

407 East Lancaster Avenue

Wayne, PA 19087

Premier Value Pediatric

GLYCERIN
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-161
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-161-00	25 in 1 JAR; Type 0: Not a Combination Product	03/21/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/21/2012

Labeler - Chain Drug Consortium LLC (101668460)

Registrant - DSC Laboratories, Inc. (097807374)

Name	Address	ID/FEI	Business Operations
Establishment
DSC Laboratories, Inc.		097807374	manufacture(68016-161)

Premier Value Pediatric Glycerin Supp