Drug Facts

Composition & Product

Active Ingredients

Caffeine (200 mg)

Inactive Ingredients

Titanium Dioxide Silicon Dioxide Carnauba Wax Polyethylene Glycol 300 Cellulose, Microcrystalline Magnesium Stearate Dextrates

Identifiers & Packaging

Pill Appearance

Imprint: TCL363 Shape: round Color: white Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-10-15

Medication Information

Warnings and Precautions

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 heart beat.

Stop use and ask a doctor if fatigue or drowsiness persists or

continues to recur.

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 Ingredients Caffeine 200mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive

Ingredients: carnauba wax, colloidal silicon

dioxide, dextrates, hypromellose, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, titanium

dioxide

Section 51945-4

MM1

Section 53414-9

If pregnant or

breast-feeding, ask a health professional before use.

Section 55105-1

Alertness Aid

Section 55106-9

Active Ingredients Caffeine 200mg

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. 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 heart beat.

Stop use and ask a doctor if fatigue or drowsiness persists or

continues to recur.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive

Ingredients: carnauba wax, colloidal silicon

dioxide, dextrates, hypromellose, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, titanium

dioxide

Section 51945-4 (51945-4)

MM1

Section 53414-9 (53414-9)

If pregnant or

breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Alertness Aid

Section 55106-9 (55106-9)

Active Ingredients Caffeine 200mg

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 300", "unii": "5655G9Y8AQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRATES", "unii": "G263MI44RU", "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. 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 heart beat. Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur. ", "50565-1": "KEEP OUT OF REACH OF CHILDREN.", "51727-6": "Inactive Ingredients: carnauba wax, colloidal silicon dioxide, dextrates, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "51945-4": "MM1", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Alertness Aid", "55106-9": "Active Ingredients Caffeine 200mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information