STAY AWAKE- caffeine tablet 
Freds 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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Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Uses

Warnings

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur.

If pregnant or breast-feeding,

ask a health care 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

cellulose*, croscarmellose sodium*, D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate*, starch*

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Stay Awake

Caffeine, 200 mg

Maximum Strength Alertness Aid

Safe & Effective

Compare to the active ingredient in Vivarin®**

DISTRIBUTED BY:  fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

**This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Vivarin®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT USE ONLY IF BLISTERS ARE INTACT

Package Label

Caffeine, 200 mg

fred's Stay Awake Tablets

 

STAY AWAKE 
caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-250
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 200 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 212;212
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-250-16 2 in 1 CARTON
1 8 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part340 03/01/2013
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013
Document Id: 4a3fc395-654b-4156-9541-4e0918cb4dfb
Set id: 29af389e-044b-4415-a81e-5bbe63c21f3f
Version: 1
Effective Time: 20130213
 
Freds Inc