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.

Enter section text here

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

PRINCIPAL DISPLAY PANEL

NDC 54868-6186-0

Infant
GLYCERIN
SUPPOSITORIES

Rectal evacuant
For relief of
temporary constipation

12 Infant Suppositories

image of package label for 12

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

Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146

INFANT GLYCERIN LAXATIVE
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-6186(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:54868-6186-0	12 in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part334	10/27/2010

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel