KONDREMUL (MINERAL OIL) LIQUID [INSIGHT PHARMACEUTICALS LLC]

KONDREMUL (MINERAL OIL) LIQUID [INSIGHT PHARMACEUTICALS LLC]
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NDC 63736-042-16
Set ID fca59a65-5eaf-41dd-8ef6-7928c209189e
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • 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 (1-800-222-1222) 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, Mapleine Triple Oil, Purified Water, Titanium Dioxide, Vanillin

  • Questions?

    1-800-344-7239

  • PRINCIPAL DISPLAY PANEL

    KONDREMUL® 
    LUBRICANT LAXATIVE

    Mineral Oil (microemulsion)

    16 FL. OZ. (480 ML)

    KONDREMUL® 
LUBRICANT LAXATIVE
Mineral Oil (microemulsion)
16 FL. OZ. (480 ML)

  • INGREDIENTS AND APPEARANCE
    KONDREMUL 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL2.12 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Acacia (UNII: 5C5403N26O)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    ColorWHITE (Opaque white) Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-042-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33406/05/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)

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