Excedrin

Manufacturer
Haleon US Holdings LLC
Effective date
2026-02-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:57

Label at a glance#

ProductExcedrin Rapid Relief
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-855-297-3031

Additional Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Excedrin

Rapid Relief

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

RELIEF STARTS IN 15 MINS

80CAPLETS

ACTUAL SIZE

Excedrin Rapid Relief 80 ct
Excedrin Rapid Relief 80 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2200-20ExcedrinRapid Relief20 in 1 BOTTLETABLET202
0067-2200-20ExcedrinRapid Relief1 in 1 CARTONTABLET12
0067-2200-80ExcedrinRapid Relief1 in 1 CARTONTABLET12
0067-2200-80ExcedrinRapid Relief80 in 1 BOTTLETABLET802
0067-2200-82ExcedrinRapid Relief1 in 1 CARTONTABLET12
0067-2200-82ExcedrinRapid Relief160 in 1 BOTTLETABLET1602

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-22000067-2200-20, 0067-2200-80, 0067-2200-82

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
ndc (package): 0067-2200-82
ndc (package): 0067-2200-80
ndc (package): 0067-2200-20
ndc (product): 0067-2200
ndc11 (package): 00067220020
ndc11 (package): 00067220080
ndc11 (package): 00067220082
spl id: 4b6b07e6-a9df-37df-e063-6394a90a3157
spl set id: 3a36b7ca-396e-cfd8-e063-6294a90a76ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.