Acetaminophen

Manufacturer
FAMILY DOLLAR
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:27:33

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

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
■ 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 reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose warning:

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right 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 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

STORAGE AND HANDLING SECTION

■ 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 8:00 AM EST to 5:00 PM PST

Pricipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APAP 500mgAPAP 500mgAPAP 500mg 24ctAPAP 500mg 24ctAPAP 500mgAPAP 500mgAPAP 500mgAPAP 500mgAPAP 500mg 500ctAPAP 500mg 500ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN6
198440acetaminophen 500 MG Oral TabletSCD6
198440APAP 500 MG Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-177-05Acetaminophen50 in 1 BOTTLETABLET506
55319-177-10Acetaminophen100 in 1 BOTTLETABLET1006
55319-177-24Acetaminophen24 in 1 BOTTLETABLET246
55319-177-25Acetaminophen250 in 1 BOTTLETABLET2506
55319-177-50Acetaminophen500 in 1 BOTTLETABLET5006

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
55319-17755319-177-24, 55319-177-05, 55319-177-10, 55319-177-25, 55319-177-50

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
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
ndc (package): 55319-177-05
ndc (package): 55319-177-50
ndc (package): 55319-177-24
ndc (package): 55319-177-25
ndc (package): 55319-177-10
ndc (product): 55319-177
ndc11 (package): 55319017705
ndc11 (package): 55319017724
ndc11 (package): 55319017725
ndc11 (package): 55319017750
ndc11 (package): 55319017710
spl id: 4654c5c0-d567-0231-e063-6294a90aa741
spl set id: f8383108-0970-9f1e-e053-6294a90ad38f

Reported adverse events (FAERS/openFDA)#

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