Acetaminophen

Manufacturer
CVS PHARMACY, INC
Effective date
2023-08-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:56:36

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure17 sections

Indications and uses

■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ he common cold ■ premenstrual and menstrual cramps ■ temporarily reduces fever

Dosage and administration

■ 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 more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor

Storage and handling

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each Gelcap)

Acetaminophen, USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ he common cold

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Liver warning

WARNINGS SECTION

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

WARNINGS SECTION

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 have ever had an allergic reaction to this product or any of its ingredients

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

■ new symptoms occur

■ redness or swelling is present

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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

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 more than 10 days unless directed by a doctor

children under 12 years

■ ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

Acetaminophen, USP 500 mg Rapid Release Gelcaps

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300 count300 count225 count225 count100 count100 count50 count50 count24 count24 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 count150 count600 count600 count80 count80 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN5
198440acetaminophen 500 MG Oral TabletSCD5
198440APAP 500 MG Oral TabletSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-298-052023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602023-03-13C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602023-01-30C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-12-29C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-09-27C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-09-25C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-07-22C16284748780-1ab0e2407-266f-f274-e053-dbdaa90a6471Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-298-05Acetaminophen50 in 1 BOTTLETABLET505
69842-298-10Acetaminophen100 in 1 BOTTLETABLET1005
69842-298-15Acetaminophen150 in 1 BOTTLETABLET1505
69842-298-21Acetaminophen225 in 1 BOTTLETABLET2255
69842-298-24Acetaminophen24 in 1 BOTTLETABLET245
69842-298-30Acetaminophen300 in 1 BOTTLETABLET3005
69842-298-40Acetaminophen400 in 1 BOTTLETABLET4005
69842-298-60Acetaminophen600 in 1 BOTTLETABLET6005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-298ACETAMINOPHEN TABLET [CVS PHARMACY, INC]5Current NDC, Legacy NDC, 8 package rows20231011_852e70e2-7279-6f33-e053-2991aa0a8676.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
AcetaminophenACETAMINOPHENCVS PHARMACY, INC852e70e2-7279-6f33-e053-2991aa0a86762023-08-28WarningsExact identifier
ndc (package): 69842-298-05
ndc (package): 69842-298-15
ndc (package): 69842-298-10
ndc (package): 69842-298-24
ndc (package): 69842-298-40
ndc (package): 69842-298-21
ndc (package): 69842-298-60
ndc (package): 69842-298-30
ndc (product): 69842-298
ndc11 (package): 69842029815
ndc11 (package): 69842029810
ndc11 (package): 69842029824
ndc11 (package): 69842029840
ndc11 (package): 69842029830
ndc11 (package): 69842029805
ndc11 (package): 69842029860
ndc11 (package): 69842029821
spl id: 04020582-1e29-0e5d-e063-6394a90a3b90
spl set id: 852e70e2-7279-6f33-e053-2991aa0a8676

Reported adverse events (FAERS/openFDA)#

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