Label: DIUREX WATERCAPS- caffeine tablet, film coated
- NDC Code(s): 52389-613-01, 52389-613-42
- 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 caplet)
Caffeine Anhydrous, 200 mg....................................DiureticClose
For relief of
- temporary water weight gain
- full feeling
associated with the premenstrual and menstrual periods.Close
- Ask a doctor or pharmacist 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
- occasional rapid heart beat
The recommended dose of this product contains about as much caffeine as two cups of coffee.Close
- 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.Close
- Read all package directions and warnings before use.
- Use only as directed.
- Adults: One pill (200 mg) every 3 to 4 hours while symptoms persist.
- Drink 6 to 8 glasses of water daily.
- Recommended for use by normally healthy adults only.
- Other information
- Calcium content: 180 mg/caplet
- Identification/product description: Light green colored, oval caplets bearing the identifying mark "ALVA"
- **Contents sealed: Each Diurex caplet is sealed in a clear plastic blister with foil backing. Do ot use if seal appears broken or if product contents do not match product description.
- Serious side effects associated with the use of this product may be reported to the phone number provided on the adjacent panel.
- INACTIVE INGREDIENT
Inactive ingredients Calcium carbonate, calcium sulfate, corn starch, DC Yellow No. 10, FDC Blue No. 1, FDC Blue No. 2*, FDC Red No. 40*, Hypromellose, Magnesium silicate*, Magnesium stearate, Mineral oil*, Polyethylene glycol, Polysorbate 80*, Sodium lauryl sulfate*, Sodium starch glycolate*, Stearic acid*, Titanium dioxide* and Vanillin. *Contains one or more of these ingredients.Close
- INGREDIENTS AND APPEARANCE
caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-613 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 200 mg Inactive Ingredients Ingredient Name Strength Calcium carbonate (UNII: H0G9379FGK) Calcium sulfate dihydrate (UNII: 4846Q921YM) Starch, corn (UNII: O8232NY3SJ) D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Blue No. 2 (UNII: L06K8R7DQK) FD&C Red No. 40 (UNII: WZB9127XOA) Hypromellose (UNII: 3NXW29V3WO) Magnesium silicate (UNII: 9B9691B2N9) Magnesium stearate (UNII: 70097M6I30) Mineral oil (UNII: T5L8T28FGP) Polyethylene glycol (UNII: 3WJQ0SDW1A) Polysorbate 80 (UNII: 6OZP39ZG8H) Sodium lauryl sulfate (UNII: 368GB5141J) Sodium starch glycolate type A potato (UNII: 5856J3G2A2) Stearic acid (UNII: 4ELV7Z65AP) Titanium dioxide (UNII: 15FIX9V2JP) Vanillin (UNII: CHI530446X) Product Characteristics Color green Score no score Shape OVAL Size 15mm Flavor Imprint Code ALVA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-613-42 2 in 1 CARTON 1 NDC:52389-613-01 21 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part357 04/15/2009 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)