CAFFEINE- caffeine tablet
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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.

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Active ingredient(s)

Caffeine 200 mg

Purpose

Alertness aid

Use(s)

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

in children under 12 years
as a substitute for sleep

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.

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur

Pregnancy/Breastfeeding

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

Other information

store at controlled room temperature 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Storage

store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrose, dicalcium phosphate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active ingredient in Vivarin®*

CAFFEINE TABLETS

ALERTNESS AID

• For mental alertness

• Safe & effective

16 TABLETS 200 mg each

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV0410A22621

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Packaging

CAFFEINE
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-226
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
DEXTROSE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;226
Contains

Packaging
#	Item Code	Package Description
1	NDC:59779-226-21	1 in 1 CARTON
1		16 in 1 BLISTER PACK
2	NDC:59779-226-10	1 in 1 CARTON
2		40 in 1 BLISTER PACK
3	NDC:59779-226-31	1 in 1 CARTON
3		80 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part340	11/21/1992

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 08/2011

Document Id: 477af82b-e4d9-4036-a3b8-28a8244b2716

Set id: 7697fe93-8af5-467d-87a8-1293d6ce7110

Version: 6

Effective Time: 20110819

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED