TOPCARE STAY AWAKE MAXIMUM STRENGTH- caffeine tablet, coated

Topcare Stay Awake by

Drug Labeling and Warnings

Topcare Stay Awake by is a Otc medication manufactured, distributed, or labeled by TopCo Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Caffeine 200mg

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

limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and ocassionally rapid heartbeat.

The recommended dose of this product contains about as much caffeine as a cup of coffee.

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 doctor or Poison Control Center (1-800-222-1222)  right away.

Directions

Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours

Children under 12 years of age: do not use

Other information

• store at room temperature 68º-77ºF (20º-25ºC)
• avoid excessive heat (greater than 100°F) and humidity
• do not use if carton is opened or if blister unit is broken

Inactive ingredients

croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Questions or comments?

Call 1-888-423-0139

Principal Display Panel

Alertness Aid

INGREDIENTS AND APPEARANCE

TOPCARE STAY AWAKE  MAXIMUM STRENGTH
caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-002
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;076
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-002-84	2 in 1 CARTON	07/01/2014
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 76162-002-58	5 in 1 CARTON	07/01/2014
2		8 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 Drug	M011	07/01/2014

Labeler - TopCo Associates, LLC (006935977)