Label: STAY AWAKE- caffeine tablet
- NDC Code(s): 41163-226-10
- Packager: SUPERVALU INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 tablet)
Caffeine 200 mgClose
helps restore mental alertness or wakefulness when experiencing fatigue or drowsinessClose
For occasional use only
Caffeine warning: The recommended dose of this product contains about as much caffeine as a 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.
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 and over: take 1 tablet not more often than every 3 to 4 hours
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, dextrose, dicalcium phosphate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica gelClose
- Questions or comments?
- Principal Display Panel
compare to Vivarin® active ingredients*
caffiene 200 mg
• helps restore alertness
• safe and effective
• equal to about one up of coffee
200 mg each
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Vivarin®.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-226 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (CAFFEINE) CAFFEINE 200 mg Inactive Ingredients Ingredient Name Strength DEXTROSE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE Product Characteristics Color YELLOW Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;226 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-226-10 1 in 1 CARTON 1 40 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part340 11/21/1992 Labeler - SUPERVALU INC. (006961411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41163-226) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(41163-226)