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Infant Glycerin Laxative (Physicians Total Care, Inc.)

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SUPPOSITORY 12 SUPPOSITORY in 1 JAR (54868-6186-0) Label Information

Complete Infant Glycerin Laxative Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6186(NDC:0904-2666)
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1.3 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:54868-6186-0 12 in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part334 10/27/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel