PEDIA-LAX- glycerin suppository

Pedia-Lax by

Drug Labeling and Warnings

Pedia-Lax by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]



Active Ingredient

Glycerin 1 g

Purpose

Hyperosmotic Laxative

Uses

• for relief of occasional constipation
  
• this product usually produces bowel movement ¼ to 1 hour

Warnings

For rectal use only

May cause rectal discomfort or a 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 within 1 hour of using this product

These symptoms may indicate a serious condition.

Keep out of reach of children

to prevent accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single Daily Dosage (per 24 hours)

• 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. To produce laxative action suppository is designed to dissolve only partially, which may not be noticeable.

Other information

• Store container tightly closed
  
• Keep away from excessive heat
  
• Mouth of jar sealed for safety. If foil imprinted with green Fleet® emblem is missing or torn, do not use.

Inactive ingredients

aloe vera gel (decolorized), edetate disodium, purified water, sodium hydroxide, stearic acid

Questions?

1-866-255-6960 or www.pedia-lax.com

PRINCIPAL DISPLAY PANEL

Pedia-Lax

Glycerin Suppositories

Laxative

12 suppositories

INGREDIENTS AND APPEARANCE

PEDIA-LAX 
glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0081
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0081-12	12 in 1 JAR; Type 0: Not a Combination Product	03/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/01/2008

Labeler - C.B. Fleet Company, Inc. (003119054)