Label: DIUREX- pamabrom capsule

  • NDC Code(s): 52389-325-01, 52389-325-21, 52389-325-42
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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

  • Active ingredient (in each capsule)

    Pamabrom, 50 mg

  • Purpose

    Diuretic

  • Uses

    For the relief of

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

    associated with the premenstrual and menstrual periods

  • Warnings

  • ASK DOCTOR/PHARMACIST

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

  • STOP USE

    Stop use and ask a doctor if symptoms last for 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: Take one (1) capsule after breakfast with a full glass of water. Dose may be repeated after six (6) hours, not to exceed four (4) capsules per day.
    • 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.
    • Note: The appearance of golden-tinted urine, which may occur after taking Diurex Water Capsules, is a normal and temporary effect.
  • Other Information

    **Contents sealed: Each Diurex capsule bears the identifying mark "ALVA" in red, contains white, blue and golden colored beads and is sealed closed with a blue band, then further sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if contents do not match product description. You may report serious side effects to the phone number provided under Questions? below.

  • Inactive ingredients

    Butyl alcohol, citric acid, FDC Blue #1 Lake, FDC Red #40 Lake, gelatin, magnesium oxide, polysorbate, potassium sorbate, povidone, propylene glycol, riboflavin, shellac, sodium hydroxide, starch, sucrose and titanium dioxide.

  • QUESTIONS

    Questions?  1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    DiurexCapsulesPDP

  • INGREDIENTS AND APPEARANCE
    DIUREX 
    pamabrom capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCROSE (UNII: C151H8M554)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (Clear, colorless capsule containing blue, white and golden beads, sealed closed with a blue band.) Scoreno score
    ShapeCAPSULE (Clear number 1 capsule) Size19mm
    FlavorImprint Code ALVA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-325-422 in 1 CARTON10/01/2006
    1NDC:52389-325-0121 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:52389-325-211 in 1 CARTON04/01/2005
    2NDC:52389-325-0121 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02704/01/2005
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)