Children’s Glycerin Suppositories 1.2 g

Drug Facts

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

Purpose

Laxative

Uses

for relief of occasional constipation
this product usually produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

Do not use for longer than one week unless directed by a doctor

Ask a doctor before use if the child has

stomach pain, nausea or vomiting
a sudden change in bowel habits lasting more than 2 weeks

When using this product your child may have rectal discomfort or a burning sensation

Stop use and ask a doctor if child has

rectal bleeding
no bowel movement after using this product

These 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 to under 6 years of age : 1 suppository once daily
children under 2 years : ask a doctor
insert 1 suppository well up into the rectum and retain for 15 minutes
it need not melt to produce laxative action

Other information

keep away from excessive heat.

Inactive ingredients purified water, sodium stearate

Questions or Comments? Call 1-844-474-7464

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Made in India

CODE NO.: MH/DRUGS/25-KD/724

Issued: 08/2023

NDC 57237-326-52 (5 blisters of 5 suppositories)

Children's Glycerin Suppositories 1.2 g

LAXATIVE

For fast, gentle relief of occasional constipation

For ages 2 to 5 years

Gly-child-supp-01

Gly-child-supp-02

NDC 57237-326-51 (5 suppositories in 1 blister pack)

Front Foil

Gly-child-supp-03

Back Foil

Gly-child-supp-04

GLYCERIN CHILDREN
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57237-326
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 STEARATE (UNII: QU7E2XA9TG)

Product Characteristics
Color	white (clear)	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57237-326-21	2 in 1 CARTON	08/24/2023	11/30/2026
1	NDC:57237-326-16	6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:57237-326-52	5 in 1 CARTON	08/24/2023	11/30/2026
2	NDC:57237-326-51	5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007.54	08/24/2023	11/30/2026

Labeler - Rising Pharma Holdings, Inc. (116880195)

Name	Address	ID/FEI	Business Operations
Establishment
Bliss GVS Pharma Limited		675630493	manufacture(57237-326) , analysis(57237-326) , pack(57237-326)