Cvs 44-678-acetaminophen

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Starch, Corn Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Shellac Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: LB Shape: oval Color: red Color: white Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-07-24

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 gelcaps every 4 to 6 hours while symptoms last
- do not take more than 10 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Other Information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
use by expiration date on package

Inactive Ingredients

corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

CVS

Health™

NDC 69842-876-51

Regular Strength

Acetaminophen

Pain Reliever, Fever Reducer, 325 mg

Compare to Tylenol® Regular Strength

active ingredient*

actual size

365 GELCAPS

Contains No Aspirin

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Tylenol® Regular Strength.

50844 ORG042167851

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

V-11112

100% money back

guaranteed.

CVS.com/returnpolicy

CVS 44-678

Stop Use and Ask A Doctor If

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Gelcap)

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not take more than directed
adults and children 12 years and over
- take 2 gelcaps every 4 to 6 hours while symptoms last
- do not take more than 10 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Other Information (Other information)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

CVS

Health™

NDC 69842-876-51

Regular Strength

Acetaminophen

Pain Reliever, Fever Reducer, 325 mg

Compare to Tylenol® Regular Strength

active ingredient*

actual size

365 GELCAPS

Contains No Aspirin

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Tylenol® Regular Strength.

50844 ORG042167851

100% money back

guaranteed.

CVS.com/returnpolicy

CVS 44-678

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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

ask a health professional before use.

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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))

Acetaminophen 325 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information