DIUREX WATER PILLS- caffeine, magnesium salicylate tablet, coated

Diurex by

Drug Labeling and Warnings

Diurex by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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

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: 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
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	05/02/2012
1	NDC: 52389-306-01	42 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-306-42	1 in 1 CARTON	05/15/2005
2	NDC: 52389-306-01	42 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 52389-306-22	2 in 1 CARTON	05/15/2005	11/30/2018
3	NDC: 52389-306-02	11 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 52389-306-21	2 in 1 CARTON	09/15/2014	10/31/2018
4		21 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 52389-306-36	2 in 1 CARTON	02/14/2020
5		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

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)