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Kondremul (Insight Pharmaceuticals)

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LIQUID 480 mL in 1 BOTTLE (63736-012-16) Label Information

Complete Kondremul Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 5 mL/teaspoonful)

    Mineral Oil 2.5 mL


  • Purpose

    Lubricant Laxative


  • Uses

    • relieves occasional constipation
    • generally produces bowel movement in 6 to 8 hours

  • Warnings

    Do not use

    • for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing.

    Ask a doctor before use if you have

    • abdominal pain, nausea or vomiting.
    • a sudden change in bowel habits that persists over a period of 2 weeks

    Ask a doctor or pharmacist before use if you are presently taking a stool softener laxative

    When using this product do not take with meals

    Stop use and ask a doctor if

    • you notice rectal bleeding or fail to have a bowel movement after use of a laxative. This may indicate a serious condition. Discontinue use and consult a doctor.
    • you need to use this product more than 1 week

    If breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    • do not take with meals
    • shake well before using
    • adults and children 12 years of age and over:
      6–18 teaspoons per day or as directed by a doctor
    • children 6 to under 12 years of age:
      2–6 teaspoons per day or as directed by a doctor
    • the maximum daily dose may be taken as a single dose or divided in up to 3 equal parts
    • children under 6 years of age: consult a doctor

  • Inactive Ingredients

    Acacia, Benzoic Acid, Carrageenan (Irish Moss), Ethyl Vanillin, Glycerin, Mapliene Triple Oil, Purified Water, Titanium Dioxide, Vanillin


  • QUESTIONS

    Call 1-800-344-7239


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749


  • PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

    Do Not Purchase if perforated ring
    at bottom of cap is broken or missing.

    KONDREMUL®
    LUBRICANT LAXATIVE

    Mineral Oil (microemulsion)

    FOR RELIEF OF OCCASIONAL CONSTIPATION

    Promotes gentle, predictable regularity of normal
    bowel movement. Creamy liquid pours easily and
    leaves no oily aftertaste. All dosages may be
    administered plain or mixed with warm or cold water,
    milk or cocoa. Pleasant tasting and smooth acting, it
    passes through stomach and upper intestine without
    upset or dehydration. Assures soft stool by retaining
    moisture balance and mixing thoroughly with bowel
    content. Permits passage of stool without straining.

    SHAKE WELL BEFORE USING

    Store at room temperature 15°-25°C (59°-77°F)

    16 FL. OZ. (480 ML)

    69871C

    Principle Display Panel - 480 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    KONDREMUL 
    kondremul liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-012
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil 2.5 mL  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Acacia (UNII: 5C5403N26O)  
    Glycerin (UNII: PDC6A3C0OX)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE (Opaque white) Score     
    Shape Size
    Flavor VANILLA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63736-012-16 480 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part334 06/05/2009
    Labeler - Insight Pharmaceuticals (176792315)