Your browser does not support JavaScript! DIUREX ULTRA (CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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DIUREX ULTRA (caffeine) tablet, film coated
[Alva-Amco Pharmacal Companies, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each pill)

Caffeine Anhydrous, 100 mg.......................................Diuretic

Uses

For relief of

  • temporary water weight gain
  • bloat
  • swelling
  • full feeling
  • fatigue
associated with the premenstrual and menstrual periods.

Warnings


Ask a doctor before use if

  • taking any other medications
  • under 18 years of age.  Do not give to children under 12 years of age.

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

  • nervousness
  • irritability
  • sleeplessness
  • occasional rapid heart beat.
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

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults:  One pill (100 mg) or two pills (200 mg) every 3 to 4 hours wile symptoms persist.
  • Drink 6 to 8 glasses of water daily.
  • Recommended for use by normally healthy adults only.

Other information

  • Calcium content:  90 mg/pill
  • Identification:  Light green colored, round pill bearing the identifying mark "ALVA".
  • **Contents sealed:  Contents packaged in a bottle with a safety seal under the cap.  Do not use if seal appears broken or if product contents do not match product description.
  • Serious side effects associated with this product may be reported to the phone number provided below.

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 PDP

DIUREX  ULTRA
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52389-155
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Caffeine (Caffeine) Caffeine100 mg
Inactive Ingredients
Ingredient NameStrength
Acacia 
Calcium carbonate 
Croscarmellose sodium 
Ethyl vanillin 
D&C YELLOW NO. 10 
FD&C Blue No. 1 
FD&C Blue No. 2 
Hypromellose 
Magnesium silicate 
Magnesium stearate 
Maltodextrin 
Cellulose, microcrystalline  
Polyethylene glycol 600 
Polysorbate 80 
Stearic acid 
Titanium dioxide 
Lactose 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35709/01/2005
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 5/2010
 
Alva-Amco Pharmacal Companies, Inc.

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