Diurex: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each capsule)

Pamabrom, 50 mg

Purpose

Diuretic

Uses

For the relief of

• temporary water weight gain
• 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: 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.
  

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

Butyl alcohol, citric acid, FDC Blue #1 Lake, FDC Red #40 Lake, gelatin, magnesium oxide, polysorbate, potassium sorbate, povidone, propylene glycol, riboflavin, shellac, sodium hydroxide, starch, sucrose and titanium dioxide.

Questions? 1-800-792-2582

DIUREX pamabrom capsule

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-325 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 ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN MAGNESIUM OXIDE POLYSORBATE 80 POTASSIUM SORBATE POVIDONE PROPYLENE GLYCOL RIBOFLAVIN SHELLAC SODIUM HYDROXIDE SUCROSE BUTYL ALCOHOL TITANIUM DIOXIDE STARCH, CORN

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 Multilevel Packaging 1 NDC:52389-325-42 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK (52389-325-01) 1 NDC:52389-325-01 21 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (52389-325-42) 2 NDC:52389-325-21 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (52389-325-01) 2 NDC:52389-325-01 21 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (52389-325-21)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M027 04/01/2005

Labeler — Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 11/2022 Alva-Amco Pharmacal Companies, Inc.