Label: DROWZ AWAY MAXIMUM STRENGTH- caffeine tablet
- NDC Code(s): 41520-252-16
- Packager: Care One (American Sales Company)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: 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.
Updated December 28, 2012
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- Active ingredient (in each tablet)
Caffeine 200 mgClose
- helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
- the recommended dose of this product contains about as much caffeine as one cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
- For occasional use only. Not intended for use as a substitute for sleep
- do not give to children under 12 years of age
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- adults and children 12 years of age and over: take 1 tablet (200 mg) not more often than every 3 to 4 hours
- Other information
- each tablet contains: calcium 60 mg
- store at controlled room temperature 15-30°C (59-86°F)
- avoid excessive heat and humidity
* This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Vivarin®
- Inactive ingredients
D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose and silica. May also contain: cellulose, croscarmellose sodium, sodium starch glycolate and starchClose
- Principal Display Panel
compare to active ingredient in Vivarin® *
caffeine alertness aid
Each tablet contains 200 mg caffeine equal to about one cup of coffee
TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT
Distributed by: American Sales Company
4201 walden avenue, Lancaster, NY 14086
caffeine 200 mg
- INGREDIENTS AND APPEARANCE
DROWZ AWAY MAXIMUM STRENGTH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-252 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 200 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW Score no score Shape ROUND Size 11mm Flavor Imprint Code 212;212 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-252-16 2 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part340 08/31/2010 Labeler - Care One (American Sales Company) (809183973) Registrant - P and L Development of New York Corporation (800014821)