GLYCERIN LAXATIVE - glycerin suppository
Cardinal Health

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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DRUG FACTS

Active Ingredient (in each suppository)

Glycerin, USP 1.2 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 told to do so 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 ingredients

purified water, sodium hydroxide, stearic acid

PRINCIPAL DISPLAY PANEL

NDC 37205-317-63

LEADER®

Glycerin Suppositories

LAXATIVE

Compare to Fleet® active ingredient*

SATISFACTION GUARANTEED

Tamper Evident. Do not use if printed inner seal is broken or missing.

25 Pediatric Size

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 1783463

www.myleader.com
1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

*Fleet® is a registered trademark of C.B. Fleet Co., Inc.

19-10226LR2C

GLYCERIN LAXATIVE
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-317
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	1.2 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:37205-317-63	25 in 1 BOX; Type 0: Not a Combination Product	06/02/2017	06/02/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/30/2003	06/02/2017

Labeler - Cardinal Health (097537435)

Registrant - G & W Laboratories, Inc. (001271188)

Name	Address	ID/FEI	Business Operations
Establishment
G & W Laboratories, Inc.		001271188	MANUFACTURE(37205-317)

Revised: 6/2017

Document Id: 1cfbb230-868a-4ee6-aa23-e17bcb4be777

Set id: 2ba535b7-6094-ba86-6141-97ebfdbd4252

Version: 2

Effective Time: 20170602

Cardinal Health