5350-cvs

5350-cvs
SPL v4
SPL
SPL Set ID 6de63f21-c3b4-0c2f-e053-2991aa0a7886
Route
ORAL
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
Croscarmellose Starch, Pregelatinized Corn Calcium Phosphate, Dibasic, Dihydrate Microcrystalline Cellulose Silicon Dioxide Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 212;212 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-28

Description

Active ingredient (in each tablet) Caffeine 200 mg


Medication Information

Warnings and Precautions

For occasional use only

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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.

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

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*CVS™ is not affiliated with the owner of the registered trademark NoDoz® Max Strength.

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 50566-9

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

Section 50570-1

Do not use

■ in children under 12 years of age

■ as a substitute for sleep

Section 51727-6

corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

Section 51945-4

CVS™

NDC 69842-500-11

CAFFEINE

ALERTNESS AID

Caffeine, 200 mg, Alertness Aid

Compare to NoDoz® Max Strength active ingredient*

60 TABLETS

Safe & Effective

For Mental Alertness

Section 53414-9

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

Section 55105-1

Purpose

Alertness aid

Directions

adults and children 12 years of age and over: take 1/2 to 1 tablet not more often than every 3 to 4 hours

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information

each tablet contains: calcium 65 mg

■ store in a dry place at 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

Questions Or Comments?

1-800-231-4670


Structured Label Content

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings and Precautions (34071-1)

For occasional use only

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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.

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

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*CVS™ is not affiliated with the owner of the registered trademark NoDoz® Max Strength.

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 50566-9 (50566-9)

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

Section 50570-1 (50570-1)

Do not use

■ in children under 12 years of age

■ as a substitute for sleep

Section 51727-6 (51727-6)

corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

Section 51945-4 (51945-4)

CVS™

NDC 69842-500-11

CAFFEINE

ALERTNESS AID

Caffeine, 200 mg, Alertness Aid

Compare to NoDoz® Max Strength active ingredient*

60 TABLETS

Safe & Effective

For Mental Alertness

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Alertness aid

Directions

adults and children 12 years of age and over: take 1/2 to 1 tablet not more often than every 3 to 4 hours

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information

each tablet contains: calcium 65 mg

■ store in a dry place at 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

Questions Or Comments? (Questions or comments?)

1-800-231-4670


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)