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

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Diurex Capsules

Active ingredient (in each capsule)

Pamabrom, 50 mg

Purpose

Diuretic

Uses

For the relief of

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

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

DiurexCapsulesPDP

DIUREX 
pamabrom capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM50 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Clear, colorless capsule containing blue, white and golden beads, sealed closed with a blue band.) Scoreno score
ShapeCAPSULE (Clear number 1 capsule) Size19mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-325-422 in 1 CARTON10/01/2006
1NDC:52389-325-0121 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:52389-325-211 in 1 CARTON04/01/2005
2NDC:52389-325-0121 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02704/01/2005
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 12/2023
Document Id: 0b782198-58e6-5343-e063-6294a90a3713
Set id: ab10451e-ff87-4974-bec4-7ba19c5bbe65
Version: 7
Effective Time: 20231201
 
Alva-Amco Pharmacal Companies, Inc.