Label: AWAKE- caffeine tablet
- NDC Code(s): 0363-3440-11
- Packager: WALGREEN CO.
- 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 caplet)
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 (1-800-222-1222) right away.
- adults and children 12 years of age and over: take 1/2 to 1 caplet 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, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acidClose
- Questions or comments?
- Principal Display Panel
Caffeine 200 mg /
• Fast acting • Easy to swallow
Compare to Maximum Strength NoDoz® active ingredientǂǂ
ǂǂThis product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Maximum Strength NoDoz®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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walgreens.com ©2012 Walgreen Co.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-3440 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 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS STEARIC ACID STARCH, CORN Product Characteristics Color WHITE Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code 44;344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-3440-11 1 in 1 CARTON 1 60 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part340 04/14/1998 Labeler - WALGREEN CO. (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(0363-3440) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-3440)