STAY AWAKE caffeine tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
NASH-FINCH COMPANY
INN (International Name):
CAFFEINE
Composition:
CAFFEINE 200 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final

STAY AWAKE- caffeine tablet

NASH-FINCH COMPANY

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.

----------

Our Family 44-226 Delisted

Active ingredient (in each tablet)

Caffeine 200 mg

Purpos e

Alertness aid

Us es

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/Breas tfeeding

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

Principal Display Panel

Our Family®

Quality Care Since 1904

Equal to one cup of coffee

Compare to the Active Ingredient of Vivarin®*

STAY AWAKE

Caffeine 200 mg

*This product is not manufactured or distributed Meda Consumer Healthcare, owner of the registered

trademark Vivarin®.

50844 REV0412C22621

DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996

NFC BRANDS

7600 FRANCE AVE S, MPLS, MN 55435

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Our Family 4 4 -226

STAY AWAKE

caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 253-226

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: L11K75P9 2J)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

44;226

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 253-226 -21 2 in 1 CARTON

1

8 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt340

11/21/19 9 2

0 4/0 2/20 18

Labeler -

NASH-FINCH COMPANY (006962294)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(70 253-226 )

NASH-FINCH COMPANY

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(70 253-226 )

Revised: 10/2015

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