Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Caffeine Tablet
FDA Label NDC 70000-0409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Caffeine (NDC 70000-0409). 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 drug facts, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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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
5009-cardinal-label (5009 16bb Ifc)
* Please review the disclaimer below.
