195 500mg Acetaminophen Tablet

Manufacturer: Medline Industries, LP
Effective date: 2026-06-04
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: daily-update
Hydrated at: 2026-06-11 05:10:24

Label at a glance#

ProductMedline

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains associated with the common cold the flu headache toothache muscular aches backache the premenstrual and menstrual periods for the minor pain from arthritis to reduce fever

Dosage and administration

adults and children 12 years and over take 1 to 2 tablets every 6 hours while symptoms persist do not take more than 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20-25°C (68-77°F) not made with Natural Rubber Latex do not use if inner seal is broken or missing

Contacts and useful links#

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

for the temporary relief of minor aches and pains associated with

the common cold
the flu
headache
toothache
muscular aches
backache
the premenstrual and menstrual periods
for the minor pain from arthritis
to reduce fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 milligrams in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks everday 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
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

has liver disease
is a child with pain of arthritis

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

the user is 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
redness or swelling is present
symptoms do not improve
any new symptoms appear

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

adults and children 12 years and over	take 1 to 2 tablets every 6 hours while symptoms persist do not take more than 6 tablets in 24 hours, 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)
not made with Natural Rubber Latex
do not use if inner seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxy propyl methyl cellulose, polyethylene glycol, pregelatinised starch, providone K-30, purified water, sodium starch glycolate, stearic acid

Manufacturer Information

SPL UNCLASSIFIED SECTION

Made in India. Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield IL 60093 USA

1-800-MEDLINE V1 RJ23HND

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0197344036267	GTIN-13: 0197344036267 EAN-13: 0197344036267 GTIN-12: 197344036267 UPC-A: 197344036267 GTIN storage (14 digits): 00197344036267	OTCM00022 V1RJ23HND.jpg

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Medline
acetaminophen
STEARIC ACID
WATER
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
HYDROXYPROPYL METHYLCELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-195	53329-195-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STEARIC ACID	4ELV7Z65AP	IACT
WATER	059QF0KO0R	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
STARCH, CORN	O8232NY3SJ	IACT
HYDROXYPROPYL METHYLCELLULOSE	3NXW29V3WO	IACT
POVIDONE K30	U725QWY32X	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2025-01-30	full-release	2026-06-01 00:54:15

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	fc5e6f2a-e813-0666-e053-6394a90a66a7	2026-06-04	Warnings	Exact identifier ndc (package): 53329-195-30 ndc (product): 53329-195 ndc11 (package): 53329019530 spl id: 536fe5f7-5321-3c6f-e063-6294a90abb04 spl set id: fc5e6f2a-e813-0666-e053-6394a90a66a7

Reported adverse events (FAERS/openFDA)#

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