OTC Medication Information: Caffeine

CAFFEINE- caffeine tablet
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

For occasional use only

Do not use

■ in children under 12 years of age

■ as a substitute for sleep

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.

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 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

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

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

100% Money Back Guarantee

Return to place of purchase if not satisfied

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
(click image for full-size original)
CAFFEINE
caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0409
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 212;212
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0409-1 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70000-0409-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 04/05/2019
Labeler — Cardinal Health (063997360)

Revised: 06/2021 Cardinal Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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