Active Ingredient (In Each Tablet)
Caffeine 200 mg
Stay Awake Tablet
FDA Label NDC 70677-1126
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Stay Awake (NDC 70677-1126). 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 tablet), 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 heart beat.
Do Not Use
- for 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 tablet not more often than every 3 to 4 hours
- children under 12 years: do not use
Other Information
- each tablet contains: calcium 35 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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, D&C yellow #10 aluminum lake, dextrates hydrated, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions Or Comments?
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Foster & Thrive™
COMPARE TO VIVARIN®
ACTIVE INGREDIENT*
NDC 70677-1126-1
Stay Awake
Caffeine 200 mg
ALERTNESS AID
Equal to About a Cup of Coffee
ACTUAL SIZE
16 TABLETS
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Vespyr Brands,
Inc., owner of the registered trademark Vivarin®.
50844 ORG121922621 Rev. 03/23
©2023 McKesson Corporation
Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141
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Foster And Thrive 44-226 (Foster And Thrive 44 226 1)
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