WALGREENS CHILDREN GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [WALGREENS]

WALGREENS CHILDREN GLYCERIN LAXATIVE (GLYCERIN SUPPOSITORY) SUPPOSITORY [WALGREENS]
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NDC 0363-0440-25
Set ID 3f1ba363-1f9c-462e-92d1-d55b786cff6f
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART334
  • 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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