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- NDC Code(s): 52389-249-10, 52389-249-16, 52389-249-20, 52389-249-24, view more
52389-249-30, 52389-249-40, 52389-249-48, 52389-249-50, 52389-249-72
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 8, 2024
If you are a consumer or patient please visit this version.
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- Active ingredient (in each caplet)
- 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
See AlsoAcetaminophen and Pamabrom - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
DIUREXMAX
pamabrom tablet, film coatedProduct 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 50mg Inactive Ingredients Ingredient Name Strength 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) CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM) 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 8 NDC:52389-249-30 3 in 1 CARTON 07/12/2021 8 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:52389-249-50 5 in 1 CARTON 07/18/2022 9 10 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 12/20/1995 Labeler -Alva-Amco Pharmacal Companies, Inc.(042074856)
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Safety
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More Info on this Drug
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View Labeling Archives for this drug
DIUREX MAX- pamabrom tablet, film coated
Number of versions: 12
| Published Date (What is this?) | Version | Files |
|---|---|---|
| May 9, 2024 | 13 (current) | download |
| Nov 30, 2023 | 12 | download |
| Jun 27, 2022 | 11 | download |
| Oct 27, 2021 | 10 | download |
| Dec 16, 2020 | 9 | download |
| Apr 30, 2019 | 8 | download |
| Apr 23, 2019 | 7 | download |
| Apr 8, 2019 | 6 | download |
| Dec 11, 2017 | 5 | download |
| Jul 19, 2016 | 4 | download |
| Oct 9, 2010 | 2 | download |
| Oct 9, 2010 | 1 | download |
RxNorm
DIUREX MAX- pamabrom tablet, film coated
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 199158 | pamabrom 50 MG Oral Tablet | PSN |
| 2 | 199158 | pamabrom 50 MG Oral Tablet | SCD |
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NDC Codes
DIUREX MAX- pamabrom tablet, film coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 52389-249-10 |
| 2 | 52389-249-16 |
| 3 | 52389-249-20 |
| 4 | 52389-249-24 |
| 5 | 52389-249-30 |
| 6 | 52389-249-40 |
| 7 | 52389-249-48 |
| 8 | 52389-249-50 |
| 9 | 52389-249-72 |
