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 December 19, 2022

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  • Active Ingredient

    (in each suppository)
    Glycerin, USP 1.2 grams

  • Uses

    -relieves occasional constipation (irregularity)

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

  • Warnings

    For rectal use only

  • Do not use

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

  • Ask a doctor before use if your child have

    Ask a doctor before use if your child have

    - stomach pain - nausea - vomiting  - a sudden change in bowel habits that lasts over 2 weeks

  • When using this product

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

  • Stop use and ask a doctor if

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

    These could be signs of a serious condition.

  • 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...........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 years..................ask a doctor

  • Other information

    -keep tightly closed

    -avoid excessive heat

  • Inactive ingredients

    purified water, sodium hydroxide, stearic acid

  • Purpose

    Laxative

  • Product Label

    Product Label

  • 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:0363-0440-2562.5 g in 1 JAR; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/01/2016
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(0363-0440)
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