STAY AWAKE- caffeine tablet

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Fachinformation Fachinformation (SPC)

20-02-2020

Wirkstoff:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Verfügbar ab:
Salado Sales, Inc.
INN (Internationale Bezeichnung):
CAFFEINE
Zusammensetzung:
CAFFEINE 200 mg
Verabreichungsweg:
ORAL
Verschreibungstyp:
OTC DRUG
Anwendungsgebiete:
Alertness aid helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Berechtigungsstatus:
OTC monograph final
Zulassungsnummer:
57243-226-21

STAY AWAKE- caffeine tablet

Salado 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.

----------

CVP 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

for 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 right away.

Directions

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

children under 12 years: do not use

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?

1-800-426-9391

Principal Display Panel

COMPARE TO VIVARIN® ACTIVE INGREDIENT*

EACH TABLET CONTAINS

200 mg CAFFEINE EQUAL

TO ABOUT A CUP OF COFFEE

CVP

STAY AWAKE

CAFFEINE

ALERTNESS AID

16 TABLETS

200 mg EACH

AS EFFECTIVE

AS COFFEE!

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 AB,

owner of the registered trademark Vivarin .

50844 REV1219Q22621

Distributed by Consumer Value Products, Inc.

P.O. Box 6115, Temple, Texas 76502

CVPproducts.com

®

HEALTH

4 4 - 226

STAY AWAKE

caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:57243-226

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

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (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)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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:57243-226 -21 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

Salado Sales, Inc.

Labeler -

Salado Sales, Inc. (009830555)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(57243-226 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(57243-226 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(57243-226 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(57243-226 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(57243-226 )

Revised: 2/2020

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