076 - Stay Awake

076 - Stay Awake
SPL v7
SPL
SPL Set ID fda5b0a8-2c85-4a8b-97ab-777682c816e2
Route
ORAL
Published
Effective Date 2016-12-21
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 400 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

Uses

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 often 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 68º-77ºF (20º-25ºC)
  • avoid excessive heat (greater than 100ºF)
  • do not use if carton is opened or blister unit is broken
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

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, sleeplessness, and occasional 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Uses

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 often 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 68º-77ºF (20º-25ºC)
  • avoid excessive heat (greater than 100ºF)
  • do not use if carton is opened or blister unit is broken
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

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, sleeplessness, and occasional 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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