STAY AWAKE MAXIMUM STRENGTH- caffeine tablet

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

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Active ingredient:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
INN (International Name):
CAFFEINE
Composition:
CAFFEINE 200 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Alertness aid helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Authorization status:
OTC monograph final
Authorization number:
64092-020-16

STAY AWAKE MAXIMUM STRENGTH- caffeine tablet

GREAT LAKES WHOLESALE, MARKETING, & SALES, 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.

----------

Healthcare 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

heart beat.

Do not use

in children under 12 years of age

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 (1-800-222-1222) right away.

Directions

adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours

Other information

each tablet contains: calcium 35 mg

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

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, dextrates hydrated, dibasic calcium phosphate dihydrate,

FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE™

NDC 64092-020-16

Maximum Strength

Stay Awake

Caffeine 200 mg each

Alertness Aid

Equal to about a cup of coffee

*Compare to the

active ingredient

in Vivarin®

Actual Size

16 TABLETS

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

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by

Meda AB, owner of the registered trademark Vivarin®.

HEALTHCARE GUARANTEE

If you are not completely satisfied with this

product, regardless of reason, return your unused

portion to Great Lakes Wholesale for a full refund

Distributed by: Great Lakes Wholesale & Marketing L.L.C.

3729 Patterson Ave., S.E., Grand Rapids, MI 49512

www.glwholesale.com 50844 REV0719F22621

Healthcare 4 4 -226

STAY AWAKE MAXIMUM STRENGTH

caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 40 9 2-0 20

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

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 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

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:6 40 9 2-0 20 -16

2 in 1 CARTON

11/21/19 9 6

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 6

Labeler -

GREAT LAKES WHOLESALE, MARKET ING, & SALES, INC. (361925498)

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(6 40 9 2-0 20 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(6 40 9 2-0 20 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(6 40 9 2-0 20 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(6 40 9 2-0 20 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(6 40 9 2-0 20 )

Revised: 10/2019

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