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ALERTNESS AID by We Care Distributor Inc.

Dosage form: tablet, coated
Ingredients: CAFFEINE 200mg
Labeler: We Care Distributor Inc.
NDC Code: 70005-020

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.

ALERTNESS AID - Caffeine Tablets, 200 mg

Drug Facts

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

ALERTNESS AID  
caffeine tablets, 200 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-020
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
DEXTRATES 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYETHYLENE GLYCOL 1000 
TITANIUM DIOXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeTCL;343
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-020-2525 POUCH in 1 BOX
12 TABLET, COATED in 1 POUCH
2NDC:70005-020-5050 POUCH in 1 BOX
22 TABLET, COATED in 1 POUCH
3NDC:70005-020-022 POUCH in 1 POUCH
32 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34003/07/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIOperations
Time Cap Labs, Inc037052099manufacture(70005-020)

 
We Care Distributor Inc.

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Medically reviewed on Mar 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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