STAY AWAKE- caffeine tablet 
Major Pharmaceuticals

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.

----------

Major 44-226-delisted

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

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.

Do not use

  • in children under 12 years
  • as a substitute for sleep 

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

Other information

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dextrose, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-7955-44

STAY AWAKE
Maximum Strength • Alertness Aid

• For Fast Pick-Up - Safe As Coffee
• Contains 200 mg Caffeine
  Equal to About A Cup Of Coffee

*Compare to the
active ingredient in
Vivarin®

16 Tablets

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed
by Meda Consumer Healthcare, owner of the
registered trademark Vivarin®.
50844        REV0412E22621
Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA
M-17    Rev. 01/13         Re-order No. 700553

Major 44-226

Major 44-226

STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7955
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
DEXTROSE (UNII: IY9XDZ35W2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;226
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7955-442 in 1 CARTON11/21/199611/15/2021
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34011/21/199611/15/2021
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0904-7955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0904-7955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0904-7955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0904-7955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0904-7955)

Revised: 3/2019
Document Id: 7f67f32e-2a26-4136-b012-3a35171395d8
Set id: 5a1300f4-910c-4704-9180-230e26ee84f8
Version: 7
Effective Time: 20190328
 
Major Pharmaceuticals