STAY AWAKE- caffeine tablet
GREENBRIER INTERNATIONAL, 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.

----------

Assured 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

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

Questions or comments?

1-800-426-9391

Principal Display Panel

Assured™

COMPARE TO ACTIVE INGREDIENT OF
VIVARIN®*

Stay Awake

• Caffeine 200 mg
Alertness Aid / Equal to About a Cup of Coffee

Actual Size

40 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 ORG041222610

ITEM# 212438
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA

Assured 44-226

STAY AWAKE
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-2261
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
DEXTROSE (UNII: IY9XDZ35W2)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;226
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-2261-0	5 in 1 CARTON	11/21/1996	06/01/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part340	11/21/1996	06/01/2022

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(33992-2261)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(33992-2261)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(33992-2261)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(33992-2261)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(33992-2261)

Revised: 6/2022

Document Id: 68598db1-d829-4afc-b0d3-a2f0370c3ca7

Set id: 43803d36-5963-4859-bda4-1288851c712c

Version: 10

Effective Time: 20220601

GREENBRIER INTERNATIONAL, INC.