GLYCERIN CHILDREN- glycerin suppository 
Rising Pharma Holdings, Inc.

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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Children’s Glycerin Suppositories 1.2 g

Drug Facts

Active ingredient (in each suppository)

Glycerin USP, 1.2 grams

Purpose

Laxative

Uses

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-326
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.2 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
Product Characteristics
Colorwhite (clear) Score    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-326-212 in 1 CARTON08/24/2023
1NDC:57237-326-166 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:57237-326-525 in 1 CARTON08/24/2023
2NDC:57237-326-515 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/24/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)
Establishment
NameAddressID/FEIBusiness Operations
Bliss GVS Pharma Limited675630493manufacture(57237-326) , analysis(57237-326) , pack(57237-326)

Revised: 9/2023
Document Id: 3d67b8bc-8559-4539-8c33-285b5948c83b
Set id: 80a5a944-2882-4f8d-a955-ef827cead5f0
Version: 1
Effective Time: 20230912
 
Rising Pharma Holdings, Inc.