ALERT- caffeine tablet, film coated

Alert by

Drug Labeling and Warnings

Alert by is a Otc medication manufactured, distributed, or labeled by Time Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Caffeine 200 mg

PURPOSE

Purpose

Alertness aid

INDICATIONS & USAGE

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

WARNINGS

Warnings

For occasional use only

DO NOT USE

• Do not use

  • in children under 12 years of age
  • as a substitute for sleep

OTHER SAFETY INFORMATION

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

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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

STORAGE AND HANDLING

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALERT 
caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-343
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL;343
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-343-44	40 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part340	11/30/2011

Labeler - Time Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc		037052099	manufacture(49483-343)