PEDIATRIC GLYCERIN- glycerin suppository

Pediatric Glycerin by

Drug Labeling and Warnings

Pediatric Glycerin by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (in each suppository)

Glycerin, USP 1.2 grams

PURPOSE

Laxative

USES

relieves occasional constipation (irregularity)
generally produces bowel movement in 1⁄4 to 1 hour

WARNINGS

For rectal use only
Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if your child has
stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts over 2 weeks

When using this product your child may have rectal discomfort or a burning sensation

Stop use and ask a doctor if your child has rectal bleeding or fails to have a bowel movement after use of a laxative. These could be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• children 2 to under 6 years of age:

  Insert 1 suppository well into

  the rectum and retain for 15

  minutes; it need not melt to

  produce laxative action. Do

  not exceed 1 suppository daily

  or as directed by a doctor.

• children under 2:

  ask a doctor

OTHER INFORMATION

keep tightly closed
avoid excessive heat

INACTIVE INGREDIENT

purified water, sodium hydroxide, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G&W®
NDC: 0713-0102-26
Glycerin Suppositories Laxative
25 Pediatric Size
G&W Laboratories, Inc
111 Coolidge Street
South Plainfield, NJ 07080
Visit our website @ www.gwlabs.com

INGREDIENTS AND APPEARANCE

PEDIATRIC GLYCERIN  
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0102
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
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0713-0102-26	25 in 1 JAR; Type 0: Not a Combination Product	06/08/1987
2	NDC: 0713-0102-13	12 in 1 JAR; Type 0: Not a Combination Product	06/08/1987
3	NDC: 0713-0102-09	10 in 1 CARTON; Type 0: Not a Combination Product	06/08/1987
4	NDC: 0713-0102-25	25 in 1 CARTON; Type 0: Not a Combination Product	06/08/1987

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/08/1987

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

Establishment
Name	Address	ID/FEI	Business Operations
Cosette Pharmaceuticals, Inc.		116918230	analysis(0713-0102) , manufacture(0713-0102) , label(0713-0102) , pack(0713-0102)