076 - Health A2z Stay Awake

076 - Health A2z Stay Awake
SPL v5
SPL
SPL Set ID 959b50a1-3037-4f94-8bc5-651501815092
Route
ORAL
Published
Effective Date 2019-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;076 Shape: round Color: yellow Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-01

Description

Caffeine 200mg

Purpose

Alertness aid


Medication Information

Purpose

Alertness aid

Description

Caffeine 200mg

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Directions

Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours

Children under 12 years of age: do not use

Do Not Use

■ in children under 12 years of age   

■ as a substitute for sleep

Other Information

■ store at room temperature 20º-25ºC (68º-77º F).

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

■ do not use if blister package is torn or open or if imprinted seal under safety cap is broken or missing.

Active Ingredient(s)

Caffeine 200mg

Inactive Ingredients

croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium 

stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Questions Or Comments?

Call 1-888-852-0050 Monday thru Friday 9am - 5pm EST

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel
Stay Awake
When Using This Product

limit the use of caffeine containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleep-

lessness, and ocassionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop Use and Ask A Doctor If

fatigue or drowsiness persists or continues to occur.

Keep Out of Reach of Children

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


Structured Label Content

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Purpose

Alertness aid

Warnings

For occasional use only

Directions

Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours

Children under 12 years of age: do not use

Do Not Use (Do not use)

■ in children under 12 years of age   

■ as a substitute for sleep

Other Information (Other information)

■ store at room temperature 20º-25ºC (68º-77º F).

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

■ do not use if blister package is torn or open or if imprinted seal under safety cap is broken or missing.

Active Ingredient(s) (Active ingredient(s))

Caffeine 200mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium 

stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-888-852-0050 Monday thru Friday 9am - 5pm EST

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel
Stay Awake
When Using This Product (When using this product)

limit the use of caffeine containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleep-

lessness, and ocassionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

fatigue or drowsiness persists or continues to occur.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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