5009-cvs

5009-cvs
SPL v5
SPL
SPL Set ID 6d9b3926-7198-5e00-e053-2a91aa0a9580
Route
ORAL
Published
Effective Date 2025-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
D&c Yellow No. 10 Silicon Dioxide Dibasic Calcium Phosphate Dihydrate Food Yellow 3 Free Acid Starch, Pregelatinized Corn Microcrystalline Cellulose Magnesium Stearate Croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: 212;212 Shape: round Color: yellow Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-22 Until 2024-01-31

Description

Active ingredient (in each tablet) Caffeine 200 mg


Medication Information

Warnings and Precautions

Warnings

Description

Active ingredient (in each tablet) Caffeine 200 mg

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Section 34088-5

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

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*CVS™ is not affiliated with the owner of the registered trademark Vivarin®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34571

Section 50565-1

Keep out of reach of children.

Section 51945-4

CVS™

NDC 69842-509-31

CAFFEINE

ALERTNESS AID

Caffeine, 200 mg, Alertness Aid

80 TABLETS

Compare to Vivarin® active ingredient*

Safe & Effective

For Mental Alertness

Section 55105-1

Purpose

Alertness aid

Directions

adults and children 12 years of age and over: take 1 tablet not more often than every 4 hours

Do Not Use

■ as a substitute for sleep. This product is intended for occasional use only ■ in children under 12 years of age

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information

  • each tablet contains: calcium 60 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

Questions Or Comments?

1-800-231-4670

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.

Stop Use and Ask A Doctor If

fatigue or drowsiness persists or continues to recur.

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings and Precautions (34071-1)

Warnings

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*CVS™ is not affiliated with the owner of the registered trademark Vivarin®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34571

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

CVS™

NDC 69842-509-31

CAFFEINE

ALERTNESS AID

Caffeine, 200 mg, Alertness Aid

80 TABLETS

Compare to Vivarin® active ingredient*

Safe & Effective

For Mental Alertness

Section 55105-1 (55105-1)

Purpose

Alertness aid

Directions

adults and children 12 years of age and over: take 1 tablet not more often than every 4 hours

Do Not Use (Do not use)

■ as a substitute for sleep. This product is intended for occasional use only ■ in children under 12 years of age

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information (Other information)

  • each tablet contains: calcium 60 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

Questions Or Comments? (Questions or comments?)

1-800-231-4670

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 occasionally, 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 recur.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)