Pain Reliever

Pain Reliever
SPL v11
SPL
SPL Set ID afacdc0b-fb65-464e-91b8-e82ba7ecde44
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Castor Oil Hypromellose, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;175 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1993-04-02 Until 2025-11-28

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • the common cold
    • backache
    • toothache
    • 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:

  • rash
  • skin reddening
  • blisters

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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥︎CVS

Health®

Compare to the active ingredient

in Extra Strength Tylenol®*

Caplets

EXTRA STRENGTH

ACETAMINOPHEN

Caplets, 500 mg

Pain reliever, Fever reducer

Travel

Pack

TAMPER EVIDENT:

Use Only if This Blister is Intact

Actual

Size

10 CAPLETS

*This product is not manufactured

or distributed by Kenvue Inc., owner

of the registered trademark Extra

Strength Tylenol®.

50844     ORG062117503

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com®    1-800-SHOP CVS

V-40098

100% money back

guaranteed

CVS.com/returnpolicy

CVS 44-175
Stop Use and Ask A Doctor If
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

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 Caplet)

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
    • the common cold
    • backache
    • toothache
    • 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:

  • rash
  • skin reddening
  • blisters

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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥︎CVS

Health®

Compare to the active ingredient

in Extra Strength Tylenol®*

Caplets

EXTRA STRENGTH

ACETAMINOPHEN

Caplets, 500 mg

Pain reliever, Fever reducer

Travel

Pack

TAMPER EVIDENT:

Use Only if This Blister is Intact

Actual

Size

10 CAPLETS

*This product is not manufactured

or distributed by Kenvue Inc., owner

of the registered trademark Extra

Strength Tylenol®.

50844     ORG062117503

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com®    1-800-SHOP CVS

V-40098

100% money back

guaranteed

CVS.com/returnpolicy

CVS 44-175
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

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 Caplet) (Active ingredient (in each caplet))

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


Raw Label Data

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