cvs 44-531c

cvs 44-531c
SPL v16
SPL
SPL Set ID 64a1ebe7-af28-4b09-96e8-28fa4dcc52bd
Route
oral
Published
Effective Date 2025-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
starch, corn d&c red no. 27 aluminum lake d&c yellow no. 10 aluminum lake fd&c blue no. 1 aluminum lake polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified stearic acid sucralose talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;531 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2005-12-11 Until 2027-01-31

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg


Medication Information

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:

  • blisters
  • rash
  • skin reddening

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

Active Ingredient

Acetaminophen 500 mg

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

Pain reliever/fever reducer

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets 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
Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Description

Acetaminophen 500 mg

Principal Display Panel

CVS

69842-931-08

Extra Strength

ACETAMINOPHEN

Pain Reliever, Fever Reducer, 500 mg

24 FILM

COATED TABLETS

Contains No Aspirin

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Compare to

Tylenol® Extra Strength

active ingredient

This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Tylenol® Extra Strength.

50844 ORG112353108

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS

V-11112

CVS.com/returnpolicy

100% money back

guaranteed

CVS 44-531C


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
Questions Or Comments?

1-800-426-9391

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 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.

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

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:

  • blisters
  • rash
  • skin reddening

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

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 500 mg

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

Pain reliever/fever reducer

Directions
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 tablets every 6 hours while symptoms last
    • do not take more than 6 tablets 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
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Principal Display Panel (Principal display panel)

CVS

69842-931-08

Extra Strength

ACETAMINOPHEN

Pain Reliever, Fever Reducer, 500 mg

24 FILM

COATED TABLETS

Contains No Aspirin

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

Compare to

Tylenol® Extra Strength

active ingredient

This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Tylenol® Extra Strength.

50844 ORG112353108

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS

V-11112

CVS.com/returnpolicy

100% money back

guaranteed

CVS 44-531C


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
Questions Or Comments? (Questions or comments?)

1-800-426-9391

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 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.

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


Raw Label Data

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