GLYCERIN- glycerin suppository

Glycerin by

Drug Labeling and Warnings

Glycerin by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each suppository)

Glycerin 1.2 g

Purpose

Laxative

Uses

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

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

• Store container tightly closed.
• Keep away from excessive heat.
  

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

INGREDIENTS AND APPEARANCE

GLYCERIN  
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0222(NDC:46122-222)
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 HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0222-2	30 in 1 BOX, UNIT-DOSE	12/19/2018
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 17856-0222-1	60 in 1 BOX, UNIT-DOSE	12/19/2018
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/12/2013

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	relabel(17856-0222) , repack(17856-0222)