604 Acetaminophen 500MG Tablet for Adults

Manufacturer: Medline Industries, LP
Effective date: 2026-07-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: daily-update
Hydrated at: 2026-08-14 00:01:25

Label at a glance#

ProductMedline

Active ingredientACETAMINOPHEN

Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and older take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use more than 10 days unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20-25ºC (68-77ºF) protect from freezing, avoid excessive heat

Contacts and useful links#

PhonePoison Help1-800-222-1222

Websitewww.medline.com

www.medline.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 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
backache
toothache
premenstrual and menstrual cramps
headache
minor pain of arthritis
muscular aches
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 the product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If skin reaction occurs, stop use and seek medical helps 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 healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: 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 older

take 2 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours, unless directed by a doctor
do not use more than 10 days unless directed by a doctor

children under 12 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20-25ºC (68-77ºF)
protect from freezing, avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-MEDLINE (633-5463) Monday - Friday, 7 a.m. to 7 p.m. CST

Manufacturing information

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured for: Medline Industries, LP, Three Lakes Drive,

Northfield, IL 60093 USA

1-800-MEDLINE

**this product is not manufactured

or distributed by Johnson & Johnson Consumer Inc.,

distributor of Tylenol® Extra Strength Tablets

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Package LabelPeel away bottom package label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	L100303MLN_R0		OTCM00022_V2 RE26EUT_PDP Package Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Medline
Acetaminophen
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A
STEARIC ACID
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-604	53329-604-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
POVIDONE	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
STEARIC ACID	4ELV7Z65AP	IACT
STARCH, CORN	O8232NY3SJ	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medline	ACETAMINOPHEN	Medline Industries, LP	4b1d7243-b943-4e2b-e063-6294a90a2c4e	2026-07-20	Warnings	Exact identifier ndc (package): 53329-604-30 ndc (product): 53329-604 ndc11 (package): 53329060430 spl id: 52f5b946-b7ed-be59-e063-6394a90a48f2 spl set id: 4b1d7243-b943-4e2b-e063-6294a90a2c4e

Reported adverse events (FAERS/openFDA)#

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