TOPCARE 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:
Topco Associates LLC
INN (International Name):
CAFFEINE
Composition:
CAFFEINE 200 mg
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final

TOPCARE STAY AWAKE MAXIMUM STRENGTH- caffeine tablet

Topco Associates LLC

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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Topco Associates LLC. Alertness Aid Drug Facts

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

Do not use

in children under 12 years of age

as a substitute for sleep

When using this product

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.

The recommended dose of this product contains about as much caffeine as two cups of coffee.

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. (1-800-222-1222)

Directions

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

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake,

magnesium stearate, maltodextrin, microcrystalline cellulose, pregelatinized starch

Questions or comments?

1-888-423-0139

Principal Display Panel

SAFE AND EFFECTIVE

Alertness Aid

Caffeine, 200 mg each

Contains as much caffeine as two cups of coffee

actual size

COMPARE TO VIVARIN® active ingredient

200 mg EACH

Alertness Aid Carton Imag e 1

Alertness Aid Carton Imag e 2

TOPCARE STAY AWAKE MAXIMUM STRENGTH

caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -40 9

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DEXTRO SE (UNII: IY9 XDZ35W2)

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

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

Topco Associates LLC

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

L40 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -40 9 -58

5 in 1 CARTON

1

8 in 1 BLISTER PACK

2

NDC:36 8 0 0 -40 9 -73

2 in 1 CARTON

2

8 in 1 BLISTER PACK

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt340

12/14/19 9 3

Labeler -

T opco Associates LLC (006935977)

Revised: 4/2012

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