OTC Medication Information: Diurex

DIUREX- pamabrom capsule, liquid filled
Alva-Amco Pharmacal Companies, Inc.

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.

Active ingredient (in each soft gel capsule)

Solubilized 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 medication.

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

If pregnant or breastfeeding, ask a health professional before use.

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) soft gel capsule after breakfast with a full glass of water.
  • Dose may be repeated after 6 hours, not to exceed four (4) soft gel capsules 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

**Contents sealed: Each Diurex Aquagel, clear translucent blue colored, oval shaped soft gel capsule bears the identifying mark “ALVA” 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. You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

FD&C Blue #1, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol and titanium dioxide.

Questions? 1-800-792-2582

Diurex Aquagels Spanish Drug Facts
(click image for full-size original)

DiurexAquagelsPDP
(click image for full-size original)

DIUREX
pamabrom capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
POVIDONE K29/32
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE (oval soft gel capsule) Size 8mm
Flavor Imprint Code ALVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52389-136-20 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (52389-136-03)
1 NDC:52389-136-03 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (52389-136-20)
2 NDC:52389-136-40 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (52389-136-40)
3 NDC:52389-136-24 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (52389-136-24)
4 NDC:52389-136-48 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (52389-136-48)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/10/2000
Labeler — Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 09/2019 Alva-Amco Pharmacal Companies, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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