Label: DIUREX WATER PILLS- magnesium salicylate and caffeine tablet, coated
- 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.
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- 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 drugClose
Analgesic (pain reliever)Close
For temporary relief of
- temporary water weight gain
- full feeling
- minor aches and pains
associated with the premenstrual and menstrual periods.Close
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:
- facial swelling
- asthma (wheezing)
- 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.Close
- 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:
- occasional rapid heart beat
The recommended dose of this product contains about as much caffeine as one cup of coffee.Close
- 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.
- feel faint
- PREGNANCY OR BREAST FEEDING
If pregnant or breastfeeding, ask a health professional before use.Close
- 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.Close
- 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.Close
- 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.Close
- INGREDIENTS AND APPEARANCE
DIUREX WATER PILLS
caffeine, magnesium salicylate tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-306 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Magnesium salicylate (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) Magnesium salicylate 162.5 mg Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 50 mg Inactive Ingredients Ingredient Name Strength Acacia (UNII: 5C5403N26O) Calcium carbonate (UNII: H0G9379FGK) Starch, corn (UNII: O8232NY3SJ) Crospovidone (UNII: 68401960MK) FD&C Blue No. 1 (UNII: H3R47K3TBD) Hypromelloses (UNII: 3NXW29V3WO) Magnesium stearate (UNII: 70097M6I30) Maltodextrin (UNII: 7CVR7L4A2D) Methylene blue (UNII: T42P99266K) Cellulose, microcrystalline (UNII: OP1R32D61U) Mineral oil (UNII: T5L8T28FGP) Polyethylene glycol 600 (UNII: NL4J9F21N9) Polysorbate 80 (UNII: 6OZP39ZG8H) Shellac (UNII: 46N107B71O) 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 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)