GLYCERIN CHILDREN- glycerin suppository

Glycerin by

Drug Labeling and Warnings

Glycerin by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Bliss GVS Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

PURPOSE

Purpose

Laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

keep away from excessive heat.

INACTIVE INGREDIENT

Inactive ingredients purified water, sodium stearate

QUESTIONS

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Made in India

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

Issued: 08/2023

PRINCIPAL DISPLAY PANEL

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

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

Front Foil

Back Foil

INGREDIENTS AND APPEARANCE

GLYCERIN  CHILDREN
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-326
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM STEARATE (UNII: QU7E2XA9TG)

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

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

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

Labeler - Rising Pharma Holdings, Inc. (116880195)

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