FDA Label for Caffeine
View Indications, Usage & Precautions
Caffeine Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Otc - Purpose
Purpose
Alertness aid
Uses
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
For occasional use only
Otc - Do Not Use
Do not use
■ in children under 12 years of age
■ as a substitute for sleep
Otc - When Using
When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Otc - Stop Use
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 tablet not more often than every 3 to 4 hours
Other Information
■ each tablet contains: calcium 62 mg
■ store at room temperature 20-25°C (68°-77°F)
■ avoid excessive heat (greater than 100°F) or humidity
Inactive Ingredient
corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica
Questions Or Comments?
1-800-231-4670
Other
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Meda Consumer Healthcare Inc., owner of the registered trademark Vivarin®.
Dist. by CAH, Dublin, OH 43017
©2019 Cardinal Health
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Package Label.Principal Display Panel
Leader
NDC 70000-0409-1
Caffeine Tablets
Caffeine, 200mg/ Alertness Aid
For Mental Alertness
Safe & Effective
COMPARE TO VIVARIN® active ingredient*
100% Money Back Guarantee
16 Tablets
* Please review the disclaimer below.