OTC Medication Information: Caffeine

CAFFEINE- caffeine tablet
CVS Pharmacy, Inc.

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

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 ■ 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

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 and over: take 1 tablet not more often than every 3 to 4 hours

Other information

each tablet contains: calcium 62 mg

■ 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, 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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Meda Consumer Healthcare, owner of the registered trademark Vivarin®.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-34571


CVS Health

Compare to the active ingredient in Vivarin®*

Caffeine Tablets

Caffeine,200mg

Alertness aid

• For mental alertness

• Safe & effective

80 Tablets

CVS label
(click image for full-size original)
CAFFEINE
caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-509
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
D&C YELLOW NO. 10
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)
STARCH, PREGELATINIZED CORN
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
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:69842-509-10 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-509-10)
2 NDC:69842-509-21 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-509-21)
3 NDC:69842-509-31 1 BOTTLE in 1 CARTON contains a BOTTLE
3 80 TABLET in 1 BOTTLE This package is contained within the CARTON (69842-509-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 06/22/2018
Labeler — CVS Pharmacy, Inc. (062312574)

Revised: 09/2020 CVS Pharmacy, Inc.

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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