Cvs 44-519 Acetaminophen

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Croscarmellose Sodium D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L;5 Shape: oval Color: red Color: blue Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-20 Until 2023-06-21

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- toothache
- backache
- the common cold
- minor pain of arthritis
- 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 6 hours while symptoms last
- do not take more than 6 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

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

Other Information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
see end flap for expiration date and lot number

Inactive Ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

CVS _™

_{NDC 69842-915-08}

EXTRA STRENGTH

Acetaminophen

Pain reliever, Fever reducer, 500 mg

Compare to

Tylenol® Extra Strength

Rapid Release Gels

active ingredient*

24 GELCAPS

Contains No Aspirin

Actual

Size

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® Extra Strength Rapid Release Gels.

50844 ORG032251908

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-11112

CVS 44-519

Stop Use and Ask A Doctor If

new symptoms occur
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
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 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 500 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
- muscular aches
- toothache
- backache
- the common cold
- minor pain of arthritis
- 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 6 hours while symptoms last
- do not take more than 6 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)

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

Other Information (Other information)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

CVS _™

_{NDC 69842-915-08}

EXTRA STRENGTH

Acetaminophen

Pain reliever, Fever reducer, 500 mg

Compare to

Tylenol® Extra Strength

Rapid Release Gels

active ingredient*

24 GELCAPS

Contains No Aspirin

Actual

Size

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® Extra Strength Rapid Release Gels.

50844 ORG032251908

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-11112

CVS 44-519

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

new symptoms occur
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
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 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 500 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)

{"Uses": "temporarily relieves minor aches and pains due to: headache muscular aches toothache backache the common cold minor pain of arthritis 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 6 hours while symptoms last do not take more than 6 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": "if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.", "Other information": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number", "Inactive ingredients": "croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "CVS ™ NDC 69842-915-08 EXTRA STRENGTH Acetaminophen Pain reliever, Fever reducer, 500 mg Compare to Tylenol® Extra Strength Rapid Release Gels active ingredient* 24 GELCAPS Contains No Aspirin Actual Size 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® Extra Strength Rapid Release Gels. 50844 ORG032251908 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 CVS 44-519", "Stop use and ask a doctor if": "new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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 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 500 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information