Label: DIUREX MAX- pamabrom tablet, film coated
52389-249-24, view more52389-249-40, 52389-249-48, 52389-249-72
- 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 15, 2020
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- Active ingredient (in each caplet)
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- 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.
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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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) 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)