357 Super Magnum

357 Super Magnum
SPL v3
SPL
SPL Set ID 1acbee4e-6f23-4d0e-ab08-696c7d4cbd22
Route
ORAL
Published
Effective Date 2016-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 1)
Inactive Ingredients
D&c Red No. 27 Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Magnesium Stearate Cellulose, Microcrystalline Povidone Silicon Dioxide Stearic Acid Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-05-19

Description

Active ingredient (in each tablet) Caffeine 200mg


Medication Information

Warnings and Precautions

Warnings: 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.

For occasional use only.Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.

Do not give to children under 12 years of age.

Indications and Usage

Use: Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

Dosage and Administration

Directions: Adults and children 12 years of age or older: 1/2 to 1 tablet, not more often than every 3-4 hours.

Children under 12 years: do not use.

Description

Active ingredient (in each tablet) Caffeine 200mg

Section 34088-5

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

Section 50565-1

Keep out of the reach of children.

Section 51727-6

Inactive ingredients: blue #1 lake, croscarmellose sodium*, dicalcium phosphate , magnesium silicate*, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, red #27 lake,  silicon dioxide, stearic acid, sugar, and titanium dioxide*

*Contains one or more of these ingredients

Section 51945-4

Section 53413-1

Questions?

Call toll-free 1-800-428-2352 Monday through Friday, 8a.m. to 5p.m. EST.

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose: Alertness Aid

Section 55106-9

Active ingredient (in each tablet)

Caffeine 200mg

Section 60561-8

Other Information:

Each tablet contains: Calcium 48mg

Store at room temperature.

Avoid excess heat (greater than 100°F) or humidity.


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 or older: 1/2 to 1 tablet, not more often than every 3-4 hours.

Children under 12 years: do not use.

Warnings and Precautions (34071-1)

Warnings: 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.

For occasional use only.Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a doctor.

Do not give to children under 12 years of age.

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

Inactive ingredients: blue #1 lake, croscarmellose sodium*, dicalcium phosphate , magnesium silicate*, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone, red #27 lake,  silicon dioxide, stearic acid, sugar, and titanium dioxide*

*Contains one or more of these ingredients

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Call toll-free 1-800-428-2352 Monday through Friday, 8a.m. to 5p.m. EST.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, 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 200mg

Section 60561-8 (60561-8)

Other Information:

Each tablet contains: Calcium 48mg

Store at room temperature.

Avoid excess heat (greater than 100°F) or humidity.


Advanced Ingredient Data


Raw Label Data

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