Label: INFANT GLYCERIN LAXATIVE- glycerin suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 4, 2010

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  • ACTIVE INGREDIENT

    Glycerin, USP 80.7%

  • PURPOSE

    Laxative

  • USE

    For relief of occasional constipation

  • WARNINGS

    For rectal use only. May cause rectal discomfort or a burning sensation.

    Do not use

    • more than one per day
    • for a period of longer than one week unless directed by a doctor
    • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
    • if seal under product lid is damaged, missing or broken.

    Ask a doctor

    • before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
    • if you are pregnant or nursing a baby




    Stop use and ask a doctor

    if you have rectal bleeding or fail to have a bowel movement after using a laxative. This 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

    • Children 2 - 6 years of age: carefully insert one suppository well into the rectum
    • Do not use more than once per day
    • Generally produces a bowel movement in 15 minutes to 1 hour
    • Children under 2 years of age: ask a doctor.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    • Store container tightly closed
    • Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
  • INACTIVE INGREDIENTS

    sodium stearate, purified water
  • QUESTIONS


  • PACKAGE LABEL

    Sunmark®

    COMPARE TO FLEET® ACTIVE INGREDIENT*
    NDC 49348-158-05

    Laxative
    Suppositories

    Glycerin


    For fast, gentle relief of occasional constipation

    PEDIATRIC

    25 SUPPOSITORIES

    Another Quality Product
    Distributed by McKesson
    One Post Street, San
    Francisco, CA 94104
    Money Back Guarantee
    Please visit us at
    www.sunmarkbrand.com

    *This product is not manufactured or distributed by C.B.Fleet co., owner of
    the registered trademark Fleet®.


    USE ONLY IF PRINTED
    INNER SEAL IS NOT BROKEN
    OR MISSING

    label

  • INGREDIENTS AND APPEARANCE
    INFANT GLYCERIN LAXATIVE 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-158
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin1.3 g
    Inactive Ingredients
    Ingredient NameStrength
    sodium stearate (UNII: QU7E2XA9TG)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-158-0525 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33409/09/2005
    Labeler - McKesson (177667227)
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