ALERTNESS AID STAY AWAKE- caffeine tablet

Alertness Aid Stay Awake by

Drug Labeling and Warnings

Alertness Aid Stay Awake by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Alertness Aid

Active Ingredient (in each tablet)

Caffeine 200mg

Uses

• 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

Caffeine warning: 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 c ase 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 than every 3 to 4 hours

Other Information 

• Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) or humidity
• Avoid excessive heat (greater than 100°F) or  humidity
• Read all product information before using
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

• Carnauba wax
• Colloidal silicon dioxide 
• D&C yellow #10 aluminium lake
• Dextrates
• FD&C yellow#6 aluminium lake
• Hypeomellose
• Magnesium stearate
• Microcrystalline cellulose
• Polyethylene glycol
• Titanium dioxide

Questions or comments? 

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

Alertness Aid Stay Awake Caffeine 200mg / alertness AidSafe & Effective Helps Restore Alertness  Compare to Vivarin® active ingredients

Distributed by:
Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

INGREDIENTS AND APPEARANCE

ALERTNESS AID STAY AWAKE 
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-132
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-132-16	1 in 1 CARTON	05/31/2017
1		16 in 1 BOTTLE; 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	05/31/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Healthlife of USA		079656178	repack(69517-132)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(69517-132) , pack(69517-132)