Stay Awake (caffeine 200 Mg)

Drug Facts

Composition & Product

Active Ingredients

Caffeine (200 mg)

Inactive Ingredients

Carnauba Wax Croscarmellose Sodium Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Dextrates Anhydrous Dibasic Calcium Phosphate Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: ET38;AZ076;TCL343 Shape: round Color: yellow Size: 1 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-04-29

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

Indications and Usage

Use

■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Purpose

Alertness Aid

Dosage and Administration

Directions

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

Description

Active ingredient (in each tablet) Caffeine 200 mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Section 42229-5

Other information

■ store at room temperature

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

Section 50567-7

When using this product limit the use of caffeine containing medications, foods, or beverages 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 a cup of coffee.

Section 51727-6

carnauba wax*,croscarmellose sodium, colloidal silicon

dioxide*, dextrates*, D&C yellow #10 aluminum lake,

dicalcium phosphate*, FD&C red#40 lake*, FD&C yellow

#6 aluminum lake*, hypromellose, lactose*, magnesium

stearate, microcrystalline cellulose, polyethylene glycol,

silicon dioxide*, titanium dioxide

*contains one or more of these ingredients

Section 53413-1

Questions or comments?

1-888-333-9792

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Principal Display Panel

Stay Awake

Caffeine 200 mg - alertness aid

safe and effective

20 Tablets

Structured Label Content

Indications and Usage (34067-9)

Use

■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage and Administration (34068-7)

Directions

■ adults and children 12 years of age 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

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Section 42229-5 (42229-5)

Other information

■ store at room temperature

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

Section 50567-7 (50567-7)

When using this product limit the use of caffeine containing medications, foods, or beverages 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 a cup of coffee.

Section 51727-6 (51727-6)

carnauba wax*,croscarmellose sodium, colloidal silicon

dioxide*, dextrates*, D&C yellow #10 aluminum lake,

dicalcium phosphate*, FD&C red#40 lake*, FD&C yellow

#6 aluminum lake*, hypromellose, lactose*, magnesium

stearate, microcrystalline cellulose, polyethylene glycol,

silicon dioxide*, titanium dioxide

*contains one or more of these ingredients

Section 53413-1 (53413-1)

Questions or comments?

1-888-333-9792

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Alertness Aid

drug Facts (Drug Facts)

Active ingredient (in each tablet)

Caffeine 200 mg

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stay Awake

Caffeine 200 mg - alertness aid

safe and effective

20 Tablets

Advanced Ingredient Data

[{"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRATES", "unii": "G263MI44RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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": "Use ■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness", "34068-7": "Directions ■ adults and children 12 years of age 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", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222", "42229-5": "Other information ■ store at room temperature ■ avoid excessive heat (greater than 100°F) or humidity", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur", "50567-7": "When using this product limit the use of caffeine containing medications, foods, or beverages 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 a cup of coffee.", "51727-6": "carnauba wax*,croscarmellose sodium, colloidal silicon dioxide*, dextrates*, D&C yellow #10 aluminum lake, dicalcium phosphate*, FD&C red#40 lake*, FD&C yellow #6 aluminum lake*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide*, titanium dioxide *contains one or more of these ingredients", "53413-1": "Questions or comments? 1-888-333-9792", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Alertness Aid", "Drug Facts": "Active ingredient (in each tablet) Caffeine 200 mg", "PRINCIPAL DISPLAY PANEL": "Stay Awake Caffeine 200 mg - alertness aid safe and effective 20 Tablets"}