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

  • NDC Code(s): 52389-306-01, 52389-306-02, 52389-306-22, 52389-306-42, view more
    52389-306-84
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/12

If you are a consumer or patient 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

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  • Purpose

    Diuretic

    Analgesic (pain reliever)

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  • Uses


    For temporary relief of 

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

    associated with the premenstrual and menstrual periods.

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  • 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.
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  • DO NOT USE

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

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  • 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.
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  • Ask a doctor or pharmacist before use if you are

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

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  • 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.
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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 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 grasses 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 blue-tinted urine, which may occur after taking DIUREX Water Pills, is a normal and temporary effect.
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  • Other information

    Magnesium content: 10 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.

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  • Inactive ingredients

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

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    DIUREX  WATER PILLS
    caffeine, magnesium salicylate tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-306
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Magnesium salicylate (SALICYLIC ACID) Magnesium salicylate 162.5 mg
    Caffeine (Caffeine) Caffeine 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    Acacia  
    Calcium carbonate  
    Starch, corn  
    Crospovidone  
    FD&C Blue No. 1  
    Hypromelloses  
    Magnesium stearate  
    Maltodextrin  
    Methylene blue  
    Cellulose, microcrystalline  
    Mineral oil  
    Polyethylene glycol 600  
    Polysorbate 80  
    Shellac  
    Silicon dioxide  
    Sodium starch glycolate type A potato  
    Stearic acid  
    Talc  
    Titanium dioxide  
    Triacetin  
    Product Characteristics
    Color blue Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code ALVA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-306-84 2 in 1 CARTON
    1 NDC:52389-306-01 42 in 1 BLISTER PACK
    2 NDC:52389-306-42 1 in 1 CARTON
    2 NDC:52389-306-01 42 in 1 BLISTER PACK
    3 NDC:52389-306-22 2 in 1 CARTON
    3 NDC:52389-306-02 11 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/15/2005
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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