DIUREX MAX- pamabrom tablet, film 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 ingredient (in each caplet)

Pamabrom, 50 mg

Purpose

Diuretic

Uses

For the relief of

• temporary water retention
• bloating
• swelling
• full feeling

associated with the premenstrual and menstrual periods.

Warnings

Ask a doctor or pharmacist before use if you are taking any other medications.

Stop use and ask a doctor if symptoms last more than ten consecutive days.

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.
• Use only as directed.
• Adults: One (1) pill after breakfast with a full glass of water.
• Dose may be repeated after 6 hours, not to exceed four (4) pills in 24 hours.
• 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.

Other information

Calcium content: 160 mg/pill. **Contents sealed: Each DIUREX Max, light blue colored, oval shaped pill bears the identifying mark "ALVA" plus a "1" on the pill's reverse side 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. NOTE: The appearance of golden tinted urine which may occur after taking Diurex Water Pills is a normal and temporary effect. You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Calcium sulfate dihydrate, croscarmellose sodium, dicalcium phosphate, FDC Blue No. 1, hypromellose, magnesium stearate, mineral oil, polyethylene glycol, potassium gluconate, riboflavin, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.

QUESTIONS

Questions?  1-800-792-2582

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIUREX  MAX
pamabrom tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-249
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POTASSIUM GLUCONATE (UNII: 12H3K5QKN9)
RIBOFLAVIN (UNII: TLM2976OFR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ALVA;1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52389-249-20	1 in 1 CARTON	07/18/2006	04/18/2011
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 52389-249-40	1 in 1 CARTON	10/01/2015	03/31/2019
2		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 52389-249-24	1 in 1 CARTON	04/18/2011
3		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 52389-249-48	2 in 1 CARTON	07/18/2013
4		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 52389-249-16	2 in 1 CARTON	04/18/2011	05/31/2019
5		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 52389-249-10	4 in 1 CARTON	11/10/2017
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 52389-249-72	3 in 1 CARTON	06/12/2018
7		24 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
unapproved drug other		12/20/1995

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)