Label: WALGREENS CHILDREN GLYCERIN LAXATIVE- glycerin suppository suppository

  • 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 6, 2014

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredient                                                           Purpose
    (in each suppository)                                                           
    Glycerin, USP 1.2 g........................................................Laxative

  • Uses

    -relieves occasional constipation (irregularity)

    -generally produces bowel movement in 1/4 to 1 hour

  • Warnings

    For rectal use only

  • Ask a doctor before use if your child has

    Ask a doctor before use if your child has

    - stomach pain      -nausea         -vomiting

    - a sudden change in bowel habits lasting more than 2 weeks

  • Stop use and ask a doctor if 

    Stop use and ask a doctor if your child has rectal bleeding or fails to have a bowel movement after use of a laxative. 

    These could be signs of a serious condition.

  • Keep out of reach of children.

    Keep out of reach of children.

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

  • Directions

    children 2 to under 6 years                                    1 suppository, or as directed by 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

    -keep tightly closed.

    -avoid excessive heat.

  • Inactive ingredients

    Inactive ingredients

    purified water, sodium hydroxide, stearic acid

  • Product Label

    Product Label

  • Directions

    children 2 to under 6 years of age                       carefully insert 1 suppository well into the rectum and retain for 15 minutes; it need not                                                                                   melt to produce laxative action.  Do not exceed 1 suppository daily or as directed by                                                                                         a doctor.

    children under 2                                                  ask a doctor

  • Do not use

    Do not use laxative products for longer than 1 week unless directed by a doctor

  • When using this product your child

    When using this product your child may have rectal discomfort or a burning sensation.

  • INGREDIENTS AND APPEARANCE
    WALGREENS CHILDREN GLYCERIN  LAXATIVE
    glycerin suppository suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0440
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN83 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP) 8.5 g  in 100 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 1.2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 7.3 g  in 100 g
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0440-1262.5 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/06/2014
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(0363-0440)