CAFFEINE- caffeine tablet 
AAA Pharmaceutical, Inc.

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.

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Caffeine Tablets

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

Do not use in children under 12 years of age

When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, 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

For occasional use only. Not intended as a substitute for sleep.

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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dibasic calcium phosphate, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 16 Tablet Carton

RESTORE u

NDC 57344-020-01

COMPARE TO THE ACTIVE
INGREDIENT IN VIVARIN®

Stay Awake

ALERTNESS AID
Caffeine

16 TABLETS - 200 mg each

Principal Display Panel - 16 Tablet Carton
CAFFEINE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57344-020
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code LL64;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57344-020-012 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:57344-020-025 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:57344-020-0310 in 1 CARTON
38 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34012/15/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.181192162MANUFACTURE(57344-020)
Establishment
NameAddressID/FEIBusiness Operations
AAA Pharmaceutical, Inc.010411533PACK(57344-020)

Revised: 12/2012
Document Id: ebb60cf2-3eee-49ec-b08a-220e43f1f486
Set id: ea9ed764-221e-4ed7-87f9-08afa7c9df5c
Version: 1
Effective Time: 20121221
 
AAA Pharmaceutical, Inc.