DIUREX WATER PILLS- caffeine, magnesium salicylate tablet, coated 
Alva-Amco Pharmacal Companies, Inc.

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Diurex Water Pills

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

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:

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

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

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

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

Stop use and ask a doctor if

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

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?  1-800-792-2582

Diurex Water Pills Spanish Drug Facts

DiurexWaterPillsPDP

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)

Revised: 11/2023
Document Id: 0b4c9520-a065-e718-e063-6294a90a14fd
Set id: e02a39f9-1c8c-4d38-b394-3f5b7062932c
Version: 11
Effective Time: 20231129
 
Alva-Amco Pharmacal Companies, Inc.