Label: DIUREX- pamabrom capsule
- NDC Code(s): 52389-325-01, 52389-325-21, 52389-325-42
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
- Warnings
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Read all package directions and warnings before use.
- Use only as directed.
- Adults: Take one (1) capsule after breakfast with a full glass of water. Dose may be repeated after six (6) hours, not to exceed four (4) capsules 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: The appearance of golden-tinted urine, which may occur after taking Diurex Water Capsules, is a normal and temporary effect.
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Other Information
**Contents sealed: Each Diurex capsule bears the identifying mark "ALVA" in red, contains white, blue and golden colored beads and is sealed closed with a blue band, then further sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if contents do not match product description. You may report serious side effects to the phone number provided under Questions? below.
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIUREX
pamabrom capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-325 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) RIBOFLAVIN (UNII: TLM2976OFR) SHELLAC (UNII: 46N107B71O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SUCROSE (UNII: C151H8M554) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (Clear, colorless capsule containing blue, white and golden beads, sealed closed with a blue band.) Score no score Shape CAPSULE (Clear number 1 capsule) Size 19mm Flavor Imprint Code ALVA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-325-42 2 in 1 CARTON 10/01/2006 1 NDC:52389-325-01 21 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:52389-325-21 1 in 1 CARTON 04/01/2005 2 NDC:52389-325-01 21 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 Drug M027 04/01/2005 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)