Active Ingredient (In Each Caplet)
Caffeine 200 mg
Awake Tablet, Film Coated
FDA Label NDC 36800-844
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Awake (NDC 36800-844). 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, use, 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
Use
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 right away.
Directions
- adults and children 12 years and over: take 1/2 to 1 caplet not more often than every 3 to 4 hours
- children under 12 years: do not use
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, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare
health®
NDC 36800-844-11
COMPARE TO MAXIMUM
STRENGTH NODOZ®
ACTIVE INGREDIENT*
MAXIMUM STRENGTH
Awake CAFFEINE, 200 mg
Alertness Aid
• Helps Restore Mental Alertness When
Experiencing Fatigue
OUR PHARMACISTS
RECOMMEND
60 CAPLETS
actual
size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Lil' Drug Store Products, Inc., owner of the registered trademark Maximum Strength NoDoz®.
50844 REV1219A34411
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0220
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
QUALITY
GUARANTEED
Topcare 44-344 (Topcare 44 344 1) 
* Please review the disclaimer below.
