Label: DIUREX MAX- pamabrom tablet, film coated

  • NDC Code(s): 52389-249-10, 52389-249-16, 52389-249-20, 52389-249-24, view more
    52389-249-30, 52389-249-40, 52389-249-48, 52389-249-50, 52389-249-72
  • 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 June 24, 2022

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  • Active ingredient (in each caplet)

    Pamabrom, 50 mg

  • Purpose


    Diuretic

  • Uses

    For the relief of

    • temporary water retention
    • bloating
    • swelling
    • full feeling

    associated with the premenstrual and menstrual periods.

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • Directions

    • Read all package directions and warnings before use.
    • Use only as directed.
    • Adults: One (1) pill after breakfast with a full glass of water.
    • Dose may be repeated after 6 hours, not to exceed four (4) pills 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.
  • Other information

    Calcium content: 160 mg/pill. **Contents sealed: Each DIUREX Max, light blue colored, oval shaped pill bears the identifying mark "ALVA" plus a "1" on the pill'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 Pills is a normal and temporary effect. You may report serious side effects to the phone number provided under Questions? below.

  • 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, talc and titanium dioxide.

  • QUESTIONS

    Questions?  1-800-792-2582

  • SPL UNCLASSIFIED SECTION

    Diurex Max Spanish Drug Facts

  • PRINCIPAL DISPLAY PANEL

    DiurexMaxPDP

  • INGREDIENTS AND APPEARANCE
    DIUREX  MAX
    pamabrom tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-249
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    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
    ColorblueScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code ALVA;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-249-201 in 1 CARTON07/18/200604/18/2011
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:52389-249-401 in 1 CARTON10/01/201503/31/2019
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:52389-249-241 in 1 CARTON04/18/2011
    324 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:52389-249-482 in 1 CARTON07/18/2013
    424 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:52389-249-162 in 1 CARTON04/18/201105/31/2019
    58 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:52389-249-104 in 1 CARTON11/10/2017
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:52389-249-723 in 1 CARTON06/12/2018
    724 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:52389-249-303 in 1 CARTON07/12/2021
    810 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:52389-249-505 in 1 CARTON07/18/2022
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/20/1995
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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