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Stay Awake by Major Pharmaceuticals

Dosage form: tablet
Ingredients: CAFFEINE 200mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-7955

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

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.

Pregnancy/Breastfeeding

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 and over: take 1 tablet not more often than every 3 to 4 hours

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrose, dicalcium phosphate, D&C yellow #10 aluminum lake, 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

*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

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

Major 44-226

STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7955
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;226
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-7955-442 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
18 TABLET (8 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34011/21/1992
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-7955)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-7955)

Revised: 03/2013
 
Major Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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