Your browser does not support JavaScript! DIUREX WATER PILLS (CAFFEINE, MAGNESIUM SALICYLATE) TABLET, COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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DIUREX WATER PILLS (caffeine, magnesium salicylate) tablet, coated
[Alva-Amco Pharmacal Companies, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 weight gain
  • 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 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 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.

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

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 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.

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.

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.

Questions?  1-800-792-2582

Diurex Water Pills 42-ct PDP

DIUREX  WATER PILLS
caffeine, magnesium salicylate tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52389-306
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Magnesium salicylate (SALICYLIC ACID) Magnesium salicylate162.5 mg
Caffeine (Caffeine) Caffeine50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-306-842 in 1 CARTON
1NDC:52389-306-0142 in 1 BLISTER PACK
2NDC:52389-306-421 in 1 CARTON
2NDC:52389-306-0142 in 1 BLISTER PACK
3NDC:52389-306-222 in 1 CARTON
3NDC:52389-306-0211 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/15/2005
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 8/2012
 
Alva-Amco Pharmacal Companies, Inc.

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