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

the recommended dose of this product contains about as much caffeine as one 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.
For occasional use only. Not intended for use as a substitute for sleep
do not give to children under 12 years of age

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 (200 mg) not more often than every 3 to 4 hours

Other information

each tablet contains: calcium 60 mg
store at controlled room temperature 15-30°C (59-86°F)
avoid excessive heat and humidity
* This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Vivarin®

Inactive ingredients

D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose and silica. May also contain: cellulose, croscarmellose sodium, sodium starch glycolate and starch

Principal Display Panel

compare to active ingredient in Vivarin® *

Maximum strength

DROWZ-AWAY

caffeine alertness aid

Each tablet contains 200 mg caffeine equal to about one cup of coffee

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

www.care1.com

caffeine 200 mg

DROWZ AWAY MAXIMUM STRENGTH
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-252
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)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
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:41520-252-16	2 in 1 CARTON	08/31/2010	08/31/2020
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	08/31/2010	08/31/2020

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

Revised: 7/2019

Document Id: 10455c03-d970-4450-ac6f-28a0ef06f580

Set id: 573b7675-10e2-41e1-bbed-76832eacd381

Version: 2

Effective Time: 20190711

Care One (American Sales Company)