Label: GLYCERIN suppository

  • Category: HUMAN OTC DRUG LABEL

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 7, 2009

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  • ACTIVE INGREDIENT

    Glycerin, USP 2g

  • 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 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 condition.



    Keep out of reach of children

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

  • 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.
  • 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

    CVS pharmacy

    NDC 50730-1091-0
    Compare to Fleet Glycerin Suppositories
    NEW!

    GLYCERIN
    SUPPOSITORIES
    LAXATIVE

    For fast, gentle relief of
    occasional constipation

    12 ADULT SUPPOSITORIES

    Distributed by CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895

    ©CVS/pharmacy
    1-800-shop-CVS
    www.cvs.com
    #721501

    DO NOT USE IF PRINTED
    INNER SEAL IS BROKEN
    OR MISSING

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

    front label

    back label

  • INGREDIENTS AND APPEARANCE
    GLYCERIN 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1091
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin2 g
    Inactive Ingredients
    Ingredient NameStrength
    sodium stearate (UNII: QU7E2XA9TG)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-1091-012 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33407/01/2009
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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