Label: DIUREX WATER PILLS- caffeine, magnesium salicylate tablet, coated

  • NDC Code(s): 52389-306-01, 52389-306-02, 52389-306-21, 52389-306-22, view more
    52389-306-36, 52389-306-42, 52389-306-84
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 29, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients (in each pill)

    Caffeine, 50 mg

    Magnesium Salicylate (NSAID)*, 162.5 mg

    (Present as 202 mg of the Tetrahydrate)

    *Non-steroidal anti-inflammatory drug

  • Purpose

    Diuretic

    Analgesic (pain reliever)

  • Uses

    For temporary relief of

    • temporary water retention
    • bloat
    • swelling
    • full feeling
    • fatigue
    • minor aches and pains

    associated with the premenstrual and menstrual periods.

  • Warnings

    Reye's Syndrome: Children and teenagers should not use this product for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert: Magnesium Salicylate may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen or others]
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed.
  • DO NOT USE

    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer.

  • Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
    • you are taking a diuretic.
  • Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis
    • taking any other drug
  • WHEN USING

    When using this product, limit the use of caffeine containing medications, foods or beverages because too much caffeine may cause:

    • nervousness
    • irritability
    • sleeplessness
    • occasional rapid heart beat

    The recommended dose of this product contains about as much caffeine as one cup of coffee.

  • Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • pain gets worse or lasts more than 10 days.
    • fever gets worse or lasts more than 3 days.
    • redness or swelling is present.
    • ringing in the ears or loss of hearing occurs.
    • any new symptoms appear.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better.
  • 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 and use only as directed.
    • Adults: Two (2) pills every 4 to 6 hours while symptoms persist, not to exceed eight (8) pills 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: DIUREX Water Pills will not discolor urine.
  • Other information

    Magnesium content: 15 mg/pill, Calcium content: 10 mg/pill **Contents sealed: Each DIUREX blue colored, round shaped pill bears the identifying mark “ALVA" 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. You may report serious side effects to the phone number provided under Questions? below.

  • Inactive ingredients

    Acacia, calcium carbonate, corn starch, crospovidone, FD&C Blue #1 Lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin.

  • QUESTIONS

    Questions?  1-800-792-2582

  • SPL UNCLASSIFIED SECTION

    Diurex Water Pills Spanish Drug Facts

  • PRINCIPAL DISPLAY PANEL

    DiurexWaterPillsPDP

  • INGREDIENTS AND APPEARANCE
    DIUREX  WATER PILLS
    caffeine, magnesium salicylate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-306
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE162.5 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code ALVA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-306-842 in 1 CARTON05/02/2012
    1NDC:52389-306-0142 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:52389-306-421 in 1 CARTON05/15/2005
    2NDC:52389-306-0142 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:52389-306-222 in 1 CARTON05/15/200511/30/2018
    3NDC:52389-306-0211 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:52389-306-212 in 1 CARTON09/15/201410/31/2018
    421 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:52389-306-362 in 1 CARTON02/14/2020
    518 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02705/15/2005
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)