FDA.reportPublic FDA data

acetaminophen

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-05-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:39:14

Label at a glance#

Productacetaminophen
Active ingredientACETAMINOPHEN
Label structure9 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 at 20-25°C (68-77°F)

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

  • 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 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 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 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 at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Acetaminophen

PAIN RELIEVER/FEVER REDUCER

ASPIRIN FREE

FOR ADULTS

CAPLETS

Compare to the active ingredient in Extra Strength Tylenol®

Caplets 500 mg. Each

Repackaged By: Preferred Pharmaceuticals Inc.

Extra Strength APAP Tab 500mg
Extra Strength APAP Tab 500mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8070ACETAMINOPHEN TABLET [PREFERRED PHARMACEUTICALS INC.]5Legacy NDC20250508_8f4162e2-d1fa-4ad4-8977-532b4df80781.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8070-1EA - Each68788-8070acbb4cd5-0ec3-414a-bac9-e86f69aed8ae12021-10-08
68788-8070-2EA - Each68788-8070c09cf65e-758e-4f65-9d86-5ffa73be179012021-10-08
68788-8070-3EA - Each68788-8070d4f07dd5-3a56-41b5-b55b-8b189977e63712021-10-08
68788-8070-5EA - Each68788-8070b5fcdd41-452f-43a3-b2bb-df4ce4b3745712021-10-08
0904-6720-24EA - Each0904-672003f5fcf1-26d4-42a3-933a-efce614fe4a312018-09-05
0904-6720-40EA - Each0904-67204890ef93-88db-4a11-83fe-eeb3e19d935a12018-09-05
0904-6720-51EA - Each0904-67204b021127-08c3-477c-a5e5-6a4adf656ed312018-09-05
0904-6720-59EA - Each0904-6720db281eca-a672-463a-8b75-a43da8c0bad512018-10-11
0904-6720-60EA - Each0904-6720d6803552-927d-4ca4-a9fe-4df4f02e9cca12018-12-13
0904-6720-80EA - Each0904-67202fe5fcfa-ffba-49d8-bb69-f7e30364e6f512018-08-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-807068788-8070-2, 68788-8070-3, 68788-8070-5, 68788-8070-1
0904-6720

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
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2aba64ae-ed09-46e5-acca-1e342797aeef8f4162e2-d1fa-4ad4-8977-532b4df807812026-04-14WarningsExact identifier
spl set id: 8f4162e2-d1fa-4ad4-8977-532b4df80781
acetaminophenACETAMINOPHENMajor Pharmaceuticals020fa486-31f0-4e0c-84d3-5b3aaded1eeb2026-02-13WarningsExact identifier
ndc (product): 0904-6720

Reported adverse events (FAERS/openFDA)#

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