GLYCERIN- glycerin suppository

Glycerin by

Drug Labeling and Warnings

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 2.1 grams

PURPOSE

Laxative

USE

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 you have
stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

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

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

IF PREGNANT OR BREAST FEEDING

 ask a health professional before use.

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 and over: 1 suppository per day or as directed by a doctor
• children 2 to under 6 years: use pediatric glycerin suppositories
• children under 2 years: ask a doctor

insert 1 suppository well up into rectum and retain for 15 minutes
it need not melt to produce laxative action

OTHER INFORMATION

keep tightly closed
avoid excessive heat

INACTIVE INGREDIENT

purified water, sodium hydroxide, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 0713-0101-02
Glycerin Suppositories
Laxative
100 Adult Size

INGREDIENTS AND APPEARANCE

GLYCERIN  
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0101
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.1 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: 0713-0101-02	100 in 1 JAR; Type 0: Not a Combination Product	06/08/1987
2	NDC: 0713-0101-13	12 in 1 JAR; Type 0: Not a Combination Product	06/08/1987
3	NDC: 0713-0101-25	25 in 1 CARTON; Type 0: Not a Combination Product	06/08/1987
4	NDC: 0713-0101-26	25 in 1 JAR; Type 0: Not a Combination Product	06/08/1987
5	NDC: 0713-0101-51	51 in 1 JAR; Type 0: Not a Combination Product	06/08/1987
6	NDC: 0713-0101-09	10 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	MANUFACTURE(0713-0101)