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 October 28, 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.

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  • 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.
  • 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

    Adverse Drug Event Call: (800) 616-2471

  • PRINCIPAL DISPLAY PANEL

    NDC 54868-6186-0


    Infant
    GLYCERIN
    SUPPOSITORIES


    Rectal evacuant
    For relief of
    temporary constipation

    12 Infant Suppositories

    image of package label for 12

    Compare to Fleet® Glycerin Suppositories*


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


    Distributed by:
    Major Pharmaceuticals
    31778 Enterprise Drive
    Livonia, MI 48150 USA

    Reorder No. 233874
    M-54 Rev 6/08

    DO NOT USE IF PRINTED
    INNER SEAL IS BROKEN
    OR MISSING



    Relabeling of "Additional Barcode Label" by:
    Physicians Total Care, Inc.
    Tulsa, OK      74146

  • INGREDIENTS AND APPEARANCE
    INFANT GLYCERIN LAXATIVE 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6186(NDC:0904-2666)
    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:54868-6186-012 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33410/27/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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