Label: PEDIA-LAX- glycerin suppository

  • NDC Code(s): 0132-0081-12
  • 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 April 23, 2020

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  • 

  • 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 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

    • 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

    PRINCIPAL DISPLAY PANEL Pedia-Lax Glycerin Suppositories Laxative 12 suppositories

  • INGREDIENTS AND APPEARANCE
    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)
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