Label: ADULT GLYCERIN LAXATIVE - glycerin suppository

  • NDC Code(s): 49348-159-05, 49348-159-09
  • Packager: McKesson
  • 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 22, 2010

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

  • ACTIVE INGREDIENT

    Glycerin, USP 80.7%

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  • PURPOSE

    Laxative

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  • USE

    For relief of occasional constipation

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  • 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 vominting 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 persist 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.

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  • DIRECTIONS

    • Adults and children 6 years of age and older: 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 6 years of age: ask a doctor.
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  • OTHER INFORMATION

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

    sodium stearate, purified water Close
  • PACKAGE LABEL - 25 count

    sunmark®                   

    COMPARE TO FLEET® ACTIVE INGREDIENT*
    NDC 49348-159-05

    Laxative
    Suppositories

    Glycerin

    For fast, gentle relief of
    occasional constipation

    ADULT

    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

    USE ONLY IF PRINTED INNER SEAL IS NOT BROKEN OR MISSING

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



    label


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  • INGREDIENTS AND APPEARANCE
    ADULT GLYCERIN LAXATIVE 
    glycerin suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-159
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin 1.614 g
    Inactive Ingredients
    Ingredient Name Strength
    sodium stearate (UNII: QU7E2XA9TG)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-159-05 25 in 1 JAR
    2 NDC:49348-159-09 50 in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part334 08/03/2005
    Labeler - McKesson (177667227)
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