Label: PEDIA-LAX- glycerin liquid

  • NDC Code(s): 0132-0190-12
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 26, 2017

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  • Active Ingredient (in each 2.7 mL average delivered dose)

    Glycerin 2.8 g, Hyperosmotic Laxative

  • Uses

    • For relief of occasional constipation
    • This product generally produces bowel movement in 1/4 to 1 hour
  • Warnings

    For rectal use only

    May cause rectal discomfort or a burning sensation.

  • Ask a doctor before using any laxative if the 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
    • if constipation continues after one week of use, contact your child's doctor
  • Stop using this product and consult a doctor if the 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

    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 yearsconsult a doctor

  • Other Information

    • carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.
  • Inactive Ingredients

    edetate disodium, purified water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Pedia-Lax Liquid Glycerin Suppositories Carton

  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0190
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.8 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0190-124 in 1 CARTON; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0190)
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