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PEN Prep Plus (PEN Prep LLC)

Available Formats

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POWDER, FOR SOLUTION 17 g in 1 BOTTLE (76334-002-02) Label Information

Complete PEN Prep Plus Information

  • OTC ACTIVE INGREDIENT SECTION

    DRUG FACTS ACTIVE INGREGIENT (IN EACH DOSE) MAGNESIUM CITRATE 17 G   SIMETHICONE 80 MG


  • INACTIVE INGREDIENT SECTION

    SUCRALOSE, LEMON FLAVOR


  • INDICATIONS AND USES

    RELIEVES OCCASIONAL CONSTIPATION (IRREGULARITY)


  • DOSAGE AND ADMINISTRATION SECTION

    FILL THIS BOTTLE TO THE TOP OF THE LABEL WITH COLD WATER OR OTHER LIQUIDS AND SHAKE THOROUGHLY. IF NEEDED, REFRIGERATE AFTER RECONSTITUTING, AND THEN SHAKE BEFORE USE. DO NOT USE AFTER 36 HOURS OF RECONSTITUTION. OR USE AS DIRECTED BY YOUR DOCTOR. CHILDREN UNDER 12, ASK YOUR DOCTOR.


  • KEEP OUT OF REACH OF CHILDREN SECTION

    KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


  • WARNINGS SECTION

    WARNINGS: ALLERGY ALERT: DO NOT USE IF YOU ARE ALLERGIC TO MAGNESIUM CITRATE OR SIMETHICONE. DO NOT EXCEED MAXIMUM DOSE IN A 24 HOUR PERIOD. ASK A DOCTOR BEFORE USE IF YOU HAVE KIDNEY DISEASE  NAUSEA, VOMITING OR ABDOMINAL PAIN  A SUDDEN CHANGE OF BOWEL HABITS FOR OVER 2 WEEKS

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING A PRESCRIPTION DRUG. TAKE THIS PRODUCT TWO OR MORE HOURS BEFORE OR AFTER OTHER DRUDS. WHEN USING THIS PRODUCT YOU MAY HAVE LOOSE, WATERY, MORE FREQUENT STOOLS.


  • PREGNANCY OR BREAST FEEDING SECTION

    IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.


  • PURPOSE SECTION

    SALINE LAXATIVE  REDUCTION OF INTESTINAL GAS


  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    PEN PREP TM  CITRATE OF MAGNESIUM PLUS  10 FL. OZ. AFTER RECONSTITUTION

    OTHER INFORMATION: TAMPER EVIDENT: DO NOT USE IF TAMPER-PROOF CAP IS OPEN OR BROKEN.

    QUESTIONS OR COMMENTS? 956-605-7590  PEN PREP L.L.C. MCALLEN, TEXAS 78504  WWW.PENRGV.COM

    PEN PREP PLUS LABEL


  • INGREDIENTS AND APPEARANCE
    PEN PREP PLUS 
    magnesium citrate powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76334-002
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE 17 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE .08 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor LEMON (LEMON FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76334-002-02 17 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 07/01/2010
    Labeler - PEN Prep LLC (968345434)
    Registrant - PEN Prep LLC (968345434)