ALERTNESS AID- caffeine tablets, 200 mg tablet, coated

ALERTNESS AID by

Drug Labeling and Warnings

ALERTNESS AID by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., Time Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)                 Purpose

Caffeine 200 mg........................................Alertness aid

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 heart beat.

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 of age or over: take 1 tablet not more often than every 3 to 4 hours

Other information

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

■ avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow no10 aluminum lake, dextrates, FD&C yellow no 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Vivarin®

ALERTNESS AID

Caffeine Tablets, 200 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each

INGREDIENTS AND APPEARANCE

ALERTNESS AID  
caffeine tablets, 200 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-020
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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL;343
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-020-25	25 in 1 BOX
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70005-020-50	50 in 1 BOX
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70005-020-02	2 in 1 POUCH
3		2 in 1 POUCH; 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	03/07/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc		037052099	manufacture(70005-020)