Label: PEN PREP- magnesium citrate powder, for solution

  • Category: HUMAN OTC DRUG LABEL

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 November 22, 2011

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  • OTC ACTIVE INGREDIENT SECTION

    DRUG FACTS ACTIVE INGREDIENT (IN EACH DOSE) MAGNESIUM CITRATE 17 G

  • PURPOSE SECTION

    SALINE LAXATIVE

  • 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.

  • INDICATIONS AND USES

    RELIEVES OCCASIONAL CONSTIPATION (IRREGULARITY)

  • WARNINGS SECTION

    WARNINGS: ALLERGY ALERT: DO NOT USE IF YOU ARE ALLERGIC TO MAGNESIUM CITRATE. 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.

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

  • 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.

  • INACTIVE INGREDIENT SECTION

    SUCRALOSE, LEMON FLAVOR

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL

    PEN PREP TM  CITRATE OF MAGNESIUM 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 LABEL

  • INGREDIENTS AND APPEARANCE
    PEN PREP 
    magnesium citrate powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76334-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE17 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (LEMON FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76334-001-0117 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/01/2010
    Labeler - PEN Prep LLC (968345434)
    Registrant - PEN Prep LLC (968345434)
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