DROWZ AWAY MAXIMUM STRENGTH- caffeine tablet
Care One (American Sales Company)

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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Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Use

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

in children under 12 years of age
as a substitute for sleep

When using this product

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.

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur

If pregnant or breast-feeding,

ask a health care 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 of age and over: take 1 tablet not more often than every 3 to 4 hours

Other information

each tablet contains: calcium 60 mg
store between 20-25°C (68-77°F)
avoid excessive heat and humidity

Inactive ingredients

D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica, starch.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Active Ingredient in Vivarin®*

CAFFEINE 200 mg

Equal to about one cup of Coffee

Alertness Aid

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

* This product is not manufactured or distributed by Meda Consumer Healthcare, distributor of Vivarin®

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Product Label

CAREONE Caffeine

DROWZ AWAY MAXIMUM STRENGTH
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-051
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	212;212
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-051-16	2 in 1 CARTON	03/05/2014	12/31/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part340	03/05/2014	12/31/2020

Labeler - Care One (American Sales Company) (809183973)

Revised: 10/2019

Document Id: 9212675c-2825-4c17-b958-e322d64a6d8a

Set id: 2cbf0040-82cc-42b4-9b32-c48c0bf2fdf7

Version: 3

Effective Time: 20191028

Care One (American Sales Company)