Label: DIUREX MAX- pamabrom tablet, film coated
view more52389-249-40, 52389-249-48
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 11, 2017
If you are a consumer or patient please visit this version.
- Active ingredient (in each caplet)
Pamabrom, 50 mgClose
For the relief of
- temporary water weight gain
- full feeling
associated with the premenstrual and menstrual periods.Close
- 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.
- Use only as directed.
- Adults: One (1) caplet after breakfast with a full glass of water.
- Dose may be repeated after 6 hours, not to exceed four (4) caplets 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/caplet. **Contents sealed: Each DIUREX Max, light blue colored, oval shaped caplet bears the identifying mark "ALVA" plus a "1" on the caplet'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 Caplets is a normal and temporary effect. You may report serious side effects to the phone number provided under Questions? below.Close
- 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 and titanium dioxide.Close
- INGREDIENTS AND APPEARANCE
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) Mineral oil (UNII: T5L8T28FGP) 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 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:52389-249-10 4 in 1 CARTON 11/13/2017 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:52389-249-16 2 in 1 CARTON 11/13/2017 6 8 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)