1020-ddm-2021-1124

1020-ddm-2021-1124
SPL v3
SPL
SPL Set ID c264a28b-424b-44f0-ac80-62849dbaf0ed
Route
ORAL
Published
Effective Date 2021-11-24
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 Calcium Phosphate, Dibasic, Anhydrous Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: LL64;57344 Shape: round Color: yellow Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-19

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.

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 50570-1

Do not use in children under 12 years of age

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 at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information
Inactive Ingredients

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

Principal Display Panel

DISCOUNT drug mart FOOD FAIR

stay awake

Caffeine • Alertness Aid

†Compare to the active ingredient in VIVARIN®

40 Tablets

200mg Each

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.

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 50570-1 (50570-1)

Do not use in children under 12 years of age

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 at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DISCOUNT drug mart FOOD FAIR

stay awake

Caffeine • Alertness Aid

†Compare to the active ingredient in VIVARIN®

40 Tablets

200mg Each

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

Caffeine 200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)