Valumeds Maximum Strength Stay Awake

Valumeds Maximum Strength Stay Awake
SPL v6
SPL
SPL Set ID 8469dd66-04b9-4232-8007-95544aa3611d
Route
ORAL
Published
Effective Date 2019-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: AZ076 Shape: round Color: yellow Size: 1 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-06

Description

Active ingredient (in each tablet)                                                                   Caffeine 200 mg

Purpose

Alertness Aid


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

Carnuba 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

VALUMEDS



MAXIMUM STRENGTH

STAY AWAKE

Caffeine 200 mg



safe and effective



250 tablets

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


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)

Carnuba 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)

VALUMEDS



MAXIMUM STRENGTH

STAY AWAKE

Caffeine 200 mg



safe and effective



250 tablets

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)