1020-car-2020-0818

1020-car-2020-0818
SPL v3
SPL
SPL Set ID 9f953ea7-2e15-2d67-e053-2a95a90a96ba
Route
ORAL
Published
Effective Date 2020-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Aluminum Oxide Calcium Phosphate, Dibasic, Anhydrous Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Starch, Pregelatinized Corn

Identifiers & Packaging

Pill Appearance
Imprint: LL64;57344 Shape: round Color: yellow Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Drug Facts

Purpose

Alertness aid


Medication Information

Purpose

Alertness aid

Description

Drug Facts

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Section 42229-5

Drug Facts

Section 50565-1

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

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 while taking this product 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 50570-1

For occasional use only

Do not use

  • in children under 12 years of age
  • as a substitute for sleep
Section 53414-9

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

Directions
  • adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours
Other Information
  • each tablet contains: calcium 80 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information and warnings
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Principal Display Panel

NDC 72476-102-01

CAREONE®

Compare to the active ingredient in Vivarin® Tablets†

STAY AWAKE

Caffeine Tablets, 200 mg

Alertness Aid

Safe and Effective

Aids in Mental Alertness

Actual Size

16 TABLETS

Active Ingredient (in Each Tablet)

Caffeine 200 mg


Structured Label Content

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

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 while taking this product 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 50570-1 (50570-1)

For occasional use only

Do not use

  • in children under 12 years of age
  • as a substitute for sleep
Section 53414-9 (53414-9)

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

Purpose

Alertness aid

Directions
  • adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours
Other Information (Other information)
  • each tablet contains: calcium 80 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information and warnings
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 72476-102-01

CAREONE®

Compare to the active ingredient in Vivarin® Tablets†

STAY AWAKE

Caffeine Tablets, 200 mg

Alertness Aid

Safe and Effective

Aids in Mental Alertness

Actual Size

16 TABLETS

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Caffeine 200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)