Pediatric Glycerin

Dosage form: suppository
Ingredients: Glycerin 1.2g
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0102

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.

Pediatric Glycerin Suppositories

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

PEDIATRIC GLYCERIN  
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0102
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (Glycerin) Glycerin1.2 g
Inactive Ingredients
Ingredient NameStrength
Stearic Acid 
Water 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1NDC:0713-0102-2625 SUPPOSITORY (SUPPOSITORY) in 1 JAR
2NDC:0713-0102-1312 SUPPOSITORY (SUPPOSITORY) in 1 JAR
3NDC:0713-0102-0910 SUPPOSITORY (SUPPOSITORY) in 1 CARTON
4NDC:0713-0102-2525 SUPPOSITORY (SUPPOSITORY) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/08/1987
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 01/2012
 
G&W Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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