Active Ingredient (In Each Caplet)
Caffeine 200 mg
Awake Tablet, Film Coated
FDA Label NDC 0363-3440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Awake (NDC 0363-3440). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Alertness aid
Uses
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
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.
Do Not Use
- in children under 12 years of age
- as a substitute for sleep
Stop Use And Ask A Doctor If
fatigue or drowsiness persists or continues to recur.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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.
Directions
- 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- 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 acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Well at
Walgreens
NDC 0363-3440-11
MAXIMUM STRENGTH
Awake
Caffeine 200 mg /
Alertness Aid
• Fast acting • Easy to swallow
60
COATED CAPLETS
Compare to Maximum Strength
NoDoz® active ingredientǂǂ
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
ǂǂThis product is not manufactured or
distributed by Novartis Consumer
Health, Inc., owner of the registered
trademark Maximum Strength NoDoz®.
50844 REV0813A34411
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
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