INFANT GLYCERIN LAXATIVE- glycerin suppository
Major Pharmaceuticals

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

: Glycerin, USP 80.7%

PURPOSE

: Laxative

USE

: For relief of occasional constipation

WARNINGS

: For rectal use only. May cause rectal discomfort or a burning sensation.

Do not use

•: more than one per day
•: for a period of longer than one week unless directed by a doctor
•: laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
•: if seal under product lid is damaged, missing or broken.

Ask a doctor

•: before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
•: if you are pregnant or nursing a baby

Stop use and ask a doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate 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 - 6 years of age: carefully insert one suppository well into the rectum
•: Do not use more than once per day
•: Generally produces a bowel movement in 15 minutes to 1 hour
•: Children under 2 years of age: ask a doctor.

OTHER INFORMATION

•: Store container tightly closed
•: Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).

INACTIVE INGREDIENTS

sodium stearate, purified water

QUESTIONS?

Adverse Drug Event Call: (800) 616-2471

PACKAGE LABEL

NDC 0904-2666-12

MAJOR

Infant
GLYCERIN
SUPPOSITORIES

Rectal evacuant
For relief of
temporary constipation

12 Infant Suppositories

Compare to Fleet® Glycerin Suppositories*

*This product is not manufactured or distributed by C.B.Fleet co., owner of
the registered trademark Fleet®.

Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA

Reorder No. 233874
M-54 Rev 6/08

DO NOT USE IF PRINTED
INNER SEAL IS BROKEN
OR MISSING

INFANT GLYCERIN LAXATIVE
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-2666
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX)	glycerin	1.3 g

Ingredient Name	Strength
Inactive Ingredients
sodium stearate (UNII: QU7E2XA9TG)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-2666-12	12 in 1 JAR; Type 0: Not a Combination Product	05/01/2007	05/12/2016
2	NDC:0904-2666-17	25 in 1 JAR; Type 0: Not a Combination Product	05/01/2007	06/17/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/01/2007	05/12/2016

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
Major Pharmaceuticals		191427277	REPACK(0904-2666)

Revised: 7/2018

Document Id: 09bf4c4a-c751-453f-917a-ae4ec212cc57

Set id: 267ac7bd-27f7-4c29-acf9-04b895843c2d

Version: 2

Effective Time: 20180724

Major Pharmaceuticals