FDA.reportPublic FDA data

196 OTCM00023 500mg Acetaminophen Cap

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 05:10:21

Label at a glance#

ProductMedline
Active ingredientACETAMINOPHEN
Label structure8 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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

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 everyday 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.

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

  • has liver disease
  • is a child with pain of arthritis

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 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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-19653329-196-30

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
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
HYDROXYPROPYL METHYLCELLULOSE3NXW29V3WOIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
ACETAMINOPHEN362O9ITL9DACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-07-01full-release2026-06-01 01:06:33

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
537007c2-5814-90aa-e063-6294a90a5c68fc5f5dcf-53a6-538d-e053-6394a90a45832026-06-04WarningsExact identifier
spl id: 537007c2-5814-90aa-e063-6294a90a5c68
spl set id: fc5f5dcf-53a6-538d-e053-6394a90a4583

Reported adverse events (FAERS/openFDA)#

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