Label: STAY AWAKE- caffeine tablet
- NDC Code(s): 55315-250-16
- Packager: Freds Inc
- 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 February 13, 2013
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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
- Inactive ingredients
cellulose*, croscarmellose sodium*, D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate*, starch*
*contains one or more of these ingredientsClose
- Questions or comments?
Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Caffeine, 200 mg
Maximum Strength Alertness Aid
Safe & Effective
Compare to the active ingredient in Vivarin®**
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
**This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Vivarin®.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT USE ONLY IF BLISTERS ARE INTACTClose
- Package Label
fred's Stay Awake TabletsClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-250 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) ALUMINUM OXIDE (UNII: LMI26O6933) 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:55315-250-16 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 03/01/2013 Labeler - Freds Inc (005866116) Registrant - P and L Development of New York Corporation (800014821)