DIUREX ULTRA- caffeine tablet, film coated 
Kobayashi Healthcare International, Inc.

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Diurex Ultra

Active ingredient (in each pill)

Caffeine Anhydrous, 100 mg

Purpose

Diuretic

Uses

For the relief of:

associated with the pre-menstrual and menstrual periods

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:

The recommended dose of this product contains about as much caffeine as one to two cups of coffee.

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 the 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, titanium dioxide.

Questions? 1-800-792-2582

Diurex Ultra Spanish Drug Facts

PDP

DIUREX  ULTRA
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-155
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE100 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
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)  
ACACIA (UNII: 5C5403N26O)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
Product Characteristics
Colorgreen (light green) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-155-8080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2005
2NDC:52389-155-901 in 1 CARTON09/01/2005
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:52389-155-022 in 1 PACKAGE01/04/2024
380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02709/01/2005
Labeler - Kobayashi Healthcare International, Inc. (156391729)
Registrant - Kobayashi America Manufacturing, LLC (079852150)

Revised: 4/2025
Document Id: 32c05c2a-5010-0362-e063-6394a90af7cf
Set id: 9a035265-40c6-43f5-8de6-6bece8449840
Version: 15
Effective Time: 20250414
 
Kobayashi Healthcare International, Inc.