PEDIA-LAX- glycerin suppository 
C.B. Fleet Company, 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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Pedia-Lax Glycerin Suppositories



Active Ingredient

Glycerin 1 g

Purpose

Hyperosmotic Laxative

Uses

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 years1 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

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

PRINCIPAL DISPLAY PANEL
Pedia-Lax 
Glycerin Suppositories
Laxative
12 suppositories

PEDIA-LAX 
glycerin suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0081
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0081-1212 in 1 JAR; Type 0: Not a Combination Product03/01/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/2008
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 4/2020
Document Id: aefc01c3-9e8b-42df-85a8-bf8ce77334e4
Set id: 9edbb46d-0b50-42e9-b9bb-c78bb10aaba3
Version: 6
Effective Time: 20200423
 
C.B. Fleet Company, Inc.