GLYCERIN - glycerin suppository 
ATLANTIC BIOLOGICALS CORP.

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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GNP Pediatric Glycerin Supp.

Active ingredient (in each suppository)

Glycerin 1.2 g

Purpose

Laxative

Uses

Warnings

For rectal use only

May cause rectal discomfort of burning sensation

Ask a Doctor before using any laxative if child has

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop use and consult a doctor if child has

  • rectal bleeding
  • no bowel movement after using this product

These symptoms 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

Single daily dosage

Children 2 to under 6 years                      1 suppository, or as directed by a doctor

children under 2 years                              ask a doctor

Insert suppository well up into rectum.

Suppository need not melt completely to produce laxative action.

Other information

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Pediatriic Glycerin Suppositories

The product shown represents a sample of that currently in use. Additional packaging may also be available.

Pediatric Glycerin Suppositories 30 & 60 per cases. 

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Ped60ct

Ped30ct

GLYCERIN  
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0222(NDC:46122-222)
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 HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0222-230 in 1 BOX, UNIT-DOSE12/19/2018
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:17856-0222-160 in 1 BOX, UNIT-DOSE12/19/2018
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/12/2013
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0222) , repack(17856-0222)

Revised: 12/2018
Document Id: 3a816cb9-cb52-4949-bf8d-099c3a6ecb92
Set id: 2b75ee96-6545-44ea-a61c-512386064bd3
Version: 1
Effective Time: 20181219
 
ATLANTIC BIOLOGICALS CORP.