Acetaminophen

Manufacturer
Pharmacy Value Alliance, LLC
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:03

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure19 sections

Indications and uses

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

Dosage and administration

■ do not take more than directed (see overdose warning) 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 use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each Caplet)

Acetaminophen, USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves minor aches and pains due to:

■ the common cold

■ headache

■ backache

■ minor pain of arthritis

■ toothache

■ muscular aches

■ 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 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

■ 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.

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 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 use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

OTHER SAFETY INFORMATION

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

■ see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 count24 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 count50 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 count100 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 count500 count

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-650-052023-01-30C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-102023-01-30C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-242023-01-30C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-502023-01-30C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-052020-12-29C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-102020-12-29C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-242020-12-29C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-502020-12-29C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-052020-09-27C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-102020-09-27C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-242020-09-27C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-502020-09-27C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-052020-09-25C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-102020-09-25C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-242020-09-25C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-502020-09-25C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-052020-07-22C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-102020-07-22C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-242020-07-22C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults
68016-650-502020-07-22C16284748780-1ab0e2407-34be-f274-e053-dbdaa90a6471Extra Strength Pain Reliever Acetaminophen Tablets, USP 500 mg (Caplets) PAIN RELIEVER/FEVER REDUCER DYE-FREE For Adults

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-650-05Acetaminophen50 in 1 BOTTLETABLET502
68016-650-10Acetaminophen100 in 1 BOTTLETABLET1002
68016-650-24Acetaminophen24 in 1 BOTTLETABLET242
68016-650-50Acetaminophen500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-650ACETAMINOPHEN TABLET [PHARMACY VALUE ALLIANCE, LLC]2Legacy NDC, 4 package rows20201230_877066b3-8bce-d78e-e053-2995a90ae958.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-65068016-650-24, 68016-650-05, 68016-650-10, 68016-650-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
b79336ba-3e82-da40-e053-2995a90a6594877066b3-8bce-d78e-e053-2995a90ae9582020-12-28WarningsExact identifier
spl id: b79336ba-3e82-da40-e053-2995a90a6594
spl set id: 877066b3-8bce-d78e-e053-2995a90ae958

Reported adverse events (FAERS/openFDA)#

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