Label: CAREONE STAY AWAKE- caffeine tablet
- NDC Code(s): 41520-708-73
- Packager: 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.
Drug Label Information
Updated February 7, 2019
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
For occasional use only
When using this product
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. The recommended dose of this product contains about as much caffeine as a cup of coffee.
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
CAREONE STAY AWAKE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-708 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 DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color YELLOW Score no score Shape ROUND Size 11mm Flavor Imprint Code L409 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-708-73 16 in 1 CARTON 02/01/2019 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part340 02/01/2019 Labeler - American Sales Company (809183973)