ALERT- caffeine tablet, film coated

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

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Active ingredient:
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Time Cap Labs, Inc
INN (International Name):
CAFFEINE
Composition:
CAFFEINE 200 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Alertness aid Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness - Do not use in children under 12 years of age as a substitute for sleep 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
Authorization status:
OTC monograph final
Authorization number:
49483-343-44

ALERT- caffeine tablet, film coated

Time Cap Labs, 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.

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343R- ALERT

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

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.

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 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

avoid excessive heat (greater than 100°F) or humidity

use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D-C yellow #10 aluminum lake, dextrates, FD-C yellow #6

aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,

titanium dioxide

ALERT

caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 48 3-343

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

DEXTRATES (UNII: G26 3MI44RU)

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

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

HYPRO MELLO SE 2 9 10 ( 15 MPA.S) (UNII: 36 SFW2JZ0 W)

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

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

PO LYETHYLENE GLYCO L 8 0 0 0 (UNII: Q6 6 2QK8 M3B)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

TCL;343

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 48 3-343-44

40 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/17/20 18

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

11/30 /20 11

Labeler -

T ime Cap Labs, Inc (037052099)

Time Cap Labs, Inc

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Time Cap Labs, Inc

0 370 520 9 9

ma nufa c ture (49 48 3-343)

Revised: 12/2018

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