343r- Alert

Drug Facts

Composition & Product

Active Ingredients

Caffeine (200 mg)

Inactive Ingredients

Carnauba Wax Silicon Dioxide D&c Yellow No. 10 Dextrates Fd&c Yellow No. 6 Hypromellose 2910 (6 Mpa.s) Hypromellose 2910 (15 Mpa.s) Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 8000 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: TCL;343 Shape: round Color: yellow Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2011-11-30

Medication Information

Warnings and Precautions

Warnings

For occasional use only

Indications and Usage

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage and Administration

Directions

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

Description

Active ingredient (in each tablet) Caffeine 200 mg

Section 44425-7

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

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur

Section 50570-1

Do not use

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

Section 51727-6

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1

Purpose

Alertness aid

Section 55106-9

Active ingredient (in each tablet)

Caffeine 200 mg

Section 60561-8

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.

Structured Label Content

Indications and Usage (34067-9)

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

For occasional use only

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur

Section 50570-1 (50570-1)

Do not use

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Alertness aid

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Caffeine 200 mg

Section 60561-8 (60561-8)

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.

Advanced Ingredient Data

[{"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRATES", "unii": "G263MI44RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (15 MPA.S)", "unii": "36SFW2JZ0W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 8000", "unii": "Q662QK8M3B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness", "34068-7": "Directions adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours", "34071-1": "Warnings For occasional use only", "44425-7": "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", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur", "50570-1": "Do not use in children under 12 years of age as a substitute for sleep", "51727-6": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Alertness aid", "55106-9": "Active ingredient (in each tablet) Caffeine 200 mg", "60561-8": "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information