OTC Medication Information: Stay Awake Maximum Strength

STAY AWAKE MAXIMUM STRENGTH- caffeine tablet
Valu Merchandisers Company (Best Choice)

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.

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

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

Maximum strength Alertness Aid

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

Stay Awake

compare to active ingredient in Vivarin® *

* This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Vivarin®

TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

Caffeine 200 mg

STAY AWAKE MAXIMUM STRENGTH caffeine tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-252 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 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE POWDERED CELLULOSE CROSCARMELLOSE SODIUM SODIUM STARCH GLYCOLATE TYPE A CORN STARCH, CORN

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:63941-252-16 2 BLISTER PACK (2 BLISTER PACK) in 1 CARTON contains a BLISTER PACK 1 8 TABLET (8 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63941-252-16)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part340 09/21/2010

Labeler — Valu Merchandisers Company (Best Choice) (868703513)

Registrant — P and L Development of New York Corporation (800014821)

Revised: 11/2012 Valu Merchandisers Company (Best Choice)