Stay Awake by Western Family Foods, Inc. Drug Facts

Stay Awake by

Drug Labeling and Warnings

Stay Awake by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STAY AWAKE- caffeine tablet 
Western Family Foods, 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.

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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 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

• each tablet contains: calcium 60 mg
• store at controlled room temperature 20º-25°C (68º-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 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

SAFE & EFFECTIVE

Maximum Strength Alertness Aid

StayAWAKE

Each Tablet Contains 200 mg Caffeine

Equal to About One Cup of Coffee

CAFFEINE ALERTNESS AID

TABLETS (200 mg each)

COMPARE TO THE ACTIVE INGREDIENT IN VIVARIN®*

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

Proudly distributed by Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 U.S.A.

www.westernfamily.com

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.

Package Label

Western Family Stay Awake Tablet

 

STAY AWAKE 
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-051
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	212212
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-051-16	16 in 1 CARTON	02/28/2014	12/31/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part340	02/28/2014	12/31/2019

Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018

Document Id: 9249bef6-415b-4092-8f1d-7ee35ea4a856

34390-5

Set id: 99ca2ffa-a0d5-40f6-a321-8a386fb3a5a7

Version: 2

Effective Time: 20181227

 

Western Family Foods, Inc.