Excedrin Tablet
FDA Label NDC 0067-2200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Excedrin (NDC 0067-2200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Acetaminophen 500 mg

Purposes

Pain reliever/Fever reducer

Uses

  • temporarily relieves minor aches and pains associated with:
    • headache
    • muscular aches
    • backache
    • minor pain from arthritis
    • the common cold
    • toothache
    • 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.

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

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

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
  • redness or swelling is present
  • any new symptoms appear

    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Overdose Warning:

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.

Directions

  • do not take more than directed(see overdose warning)
  • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • children under 12 years of age: ask a doctor

Other Information

  • each caplet contains:calcium 25 mg
  • store at 20-25°C (68-77°F)
  • close cap tightly after use

Inactive Ingredients

alginic acid, calcium carbonate, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, purified water, titanium dioxide

Questions Or Comments?

1-855-297-3031

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

Do not use if inner safety seal under cap is broken or missing.

Active ingredient made in India, further processed in the U.S.

Principal Display Panel

Excedrin

Rapid Relief

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

RELIEF STARTS IN 15 MINS

80CAPLETS

ACTUAL SIZE

* Please review the disclaimer below.