Acetaminophen

Manufacturer
Granules USA, Inc
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:27:57

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure18 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 (see overdose warning) 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.

overdose warning

OVERDOSAGE SECTION

In case of accidental overdose, get medical help or contact a Poison Control Centerright away (1-800-222-1222). 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 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 8:00 AM EST to 5:00 PM PST.

Acetaminophen, USP 500 mg Rapid Release Gelcaps

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 count100 count

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN7
198440acetaminophen 500 MG Oral TabletSCD7
198440APAP 500 MG Oral TabletSY7

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-008-10Acetaminophen100 in 1 BOTTLETABLET1007

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69848-00869848-008-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML · Source PDF

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
AcetaminophenACETAMINOPHENGranules USA, Inca51395ea-e038-dc9c-e053-2a95a90a287d2025-12-22WarningsExact identifier
ndc (package): 69848-008-10
ndc (product): 69848-008
ndc11 (package): 69848000810
spl id: 468e7582-908f-6ec4-e063-6394a90a1653
spl set id: a51395ea-e038-dc9c-e053-2a95a90a287d

Reported adverse events (FAERS/openFDA)#

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