Label: DIUREX ULTRA- caffeine tablet, film coated
- NDC Code(s): 52389-155-80
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each pill)
Caffeine Anhydrous, 100 mg.......................................DiureticClose
For relief of
- temporary water weight gain
- full feeling
- 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
When using this product, limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause:
- occasional rapid heart beat.
- STOP USE
Stop use and ask a doctor if symptoms last for more than ten consecutive days.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breastfeeding, ask a health professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- 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.Close
- INGREDIENTS AND APPEARANCE
caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-155 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Caffeine (Caffeine) Caffeine 100 mg Inactive Ingredients Ingredient Name Strength 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 Color green (light green) Score no score Shape ROUND Size 10mm Flavor Imprint Code ALVA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-155-80 80 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part357 09/01/2005 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)