Label: DIUREX MAX- pamabrom tablet, film coated

  • NDC Code(s): 52389-249-10, 52389-249-16, 52389-249-20, 52389-249-24, view more
    52389-249-40, 52389-249-48
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 11, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Pamabrom, 50 mg

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  • Purpose


    Diuretic

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  • Uses

    For the relief of

    • temporary water weight gain
    • bloating
    • swelling
    • full feeling

    associated with the premenstrual and menstrual periods.

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  • Warnings


    Ask a doctor or pharmacist before use if you are taking any other medications.

    Stop use and ask a doctor if symptoms last more than ten consecutive days.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a poison control center right away.

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  • Directions

    • Read all package directions and warnings before use.
    • Use only as directed.
    • Adults:  One (1) caplet after breakfast with a full glass of water.
    • Dose may be repeated after 6 hours, not to exceed four (4) caplets in 24 hours.
    • Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.
    • Drink 6 to 8 glasses of water daily.
    • For use by normally healthy adults only.
    • Persons under 18 years of age should use only as directed by a doctor.
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  • Other information

    Calcium content: 160 mg/caplet.  **Contents sealed:  Each DIUREX Max, light blue colored, oval shaped caplet bears the identifying mark "ALVA"  plus a "1" on the caplet's reverse side and is sealed in a clear plastic blister with a foil backing.  Do not use if seal appears broken or if product contents do not match product description.  NOTE:  The appearance of golden tinted urine which may occur after taking Diurex Water Caplets is a normal and temporary effect.  You may report serious side effects to the phone number provided under Questions? below.

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  • Inactive ingredients

    Calcium sulfate dihydrate, croscarmellose sodium, dicalcium phosphate, FDC Blue No. 1, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, potassium gluconate, riboflavin, sodium lauryl sulfate, stearic acid and titanium dioxide.

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    DIUREX  MAX
    pamabrom tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-249
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Pamabrom (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) Pamabrom 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    Calcium sulfate dihydrate (UNII: 4846Q921YM)  
    Croscarmellose sodium (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Magnesium stearate (UNII: 70097M6I30)  
    Mineral oil (UNII: T5L8T28FGP)  
    Polyethylene glycol 400 (UNII: B697894SGQ)  
    Potassium gluconate (UNII: 12H3K5QKN9)  
    Riboflavin (UNII: TLM2976OFR)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    Stearic acid (UNII: 4ELV7Z65AP)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color blue Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code ALVA;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-249-20 1 in 1 CARTON 07/18/2006 04/18/2011
    1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:52389-249-40 1 in 1 CARTON 10/01/2015
    2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:52389-249-24 1 in 1 CARTON 04/18/2011
    3 24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:52389-249-48 2 in 1 CARTON 07/18/2013
    4 24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:52389-249-10 4 in 1 CARTON 11/13/2017
    5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6 NDC:52389-249-16 2 in 1 CARTON 11/13/2017
    6 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/20/1995
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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