DIUREX WATER PILLS XPL- caffeine tablet, film coated 
Alva-Amco Pharmacal Companies, Inc.

----------

Diurex XPL

Active ingredient (in each pill)

Caffeine Anhydrous, 100 mg

Purpose

Diuretic

Uses

For relief of symptoms associated with the premenstrual and menstrual periods including:

Warnings

Ask a doctor before use if

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause:

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

Inactive ingredients

Acacia, calcium carbonate, croscarmellose sodium, D&C Yellow No. 10 Lake, ethyl vanillin, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate, stearic acid and titanium dioxide.

Questions? 1-800-792-2582

DiurexXPL Spanish Drug Facts

Diurex XPL PDP

DIUREX WATER PILLS  XPL
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-406
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE100 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ACACIA (UNII: 5C5403N26O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorgreen (light green) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-406-181 in 1 CARTON08/17/201606/30/2019
1NDC:52389-406-0218 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:52389-406-221 in 1 CARTON08/17/2016
2NDC:52389-406-0122 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02708/17/2016
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 11/2023
Document Id: 0b4d2a4d-d9f8-90e4-e063-6394a90aebf6
Set id: 9f971b95-47f4-4bd4-beec-2296b4c9cbdc
Version: 9
Effective Time: 20231129
 
Alva-Amco Pharmacal Companies, Inc.