GLYCERIN - glycerin suppository 
Cosette Pharmaceuticals, Inc.

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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Adult Glycerin

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 over1 suppository per day or as directed by a doctor
children 2 to under 6 yearsuse pediatric glycerin suppositories
children under 2 yearsask 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

Packaging Label
GLYCERIN  
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0101
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0713-0101-02100 in 1 JAR; Type 0: Not a Combination Product06/08/198709/30/2016
2NDC:0713-0101-1312 in 1 JAR; Type 0: Not a Combination Product06/08/198711/30/2016
3NDC:0713-0101-2525 in 1 CARTON; Type 0: Not a Combination Product06/08/198708/31/2019
4NDC:0713-0101-2625 in 1 JAR; Type 0: Not a Combination Product06/08/198701/31/2017
5NDC:0713-0101-5151 in 1 JAR; Type 0: Not a Combination Product06/08/198712/31/2016
6NDC:0713-0101-0910 in 1 CARTON; Type 0: Not a Combination Product06/08/198708/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/08/198708/31/2019
Labeler - Cosette Pharmaceuticals, Inc. (116918230)
Registrant - Cosette Pharmaceuticals, Inc. (116918230)
Establishment
NameAddressID/FEIBusiness Operations
Cosette Pharmaceuticals, Inc.116918230MANUFACTURE(0713-0101)

Revised: 6/2021
 
Cosette Pharmaceuticals, Inc.