Extra Strength Acetaminophen

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:15

Label at a glance#

ProductExtra Strength Acetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

• temporarily relieves minor aches and pains • temporarily reduces fever

Dosage and administration

• do not take more than directed • adults and children 12 years and over: Take 2 tablets every 6 hours, as needed; not more than 6 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor. • children under 12 years: ask a doctor

Storage and handling

• store at 20⁰C-25⁰C (68⁰F-77⁰F)

Label contents#

Full prescribing information#

Active Ingredients

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
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 8 tablets (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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use..

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical
help or contact a Poison Control Center right away. 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
  • adults and children 12 years and over: Take 2 tablets every 6 hours, as needed; not more than 6 tablets in 24 hours. Do
    not take 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 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

povidone, sodium starch glycolate, starch, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Acetaminophen 500mg
Extra Strength Acetaminophen 500mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8873-1Extra Strength Acetaminophen100 in 1 BOTTLETABLET1001
68788-8873-2Extra Strength Acetaminophen20 in 1 BOTTLETABLET201
68788-8873-3Extra Strength Acetaminophen30 in 1 BOTTLETABLET301
68788-8873-5Extra Strength Acetaminophen50 in 1 BOTTLETABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8873EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250521_95f4b628-6d35-4f6b-91f9-b2d117f8e821.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8873-1EA - Each68788-8873bf1f21d2-a608-48e0-a531-7a2b1123963812025-07-08
68788-8873-2EA - Each68788-8873b9a87529-5007-484c-a960-b284b5c709a512025-07-08
68788-8873-3EA - Each68788-88734bddc350-7378-43bb-ad4e-60865053793a12025-07-08
68788-8873-5EA - Each68788-8873a94c0b78-1fff-486b-bd3c-3d09d2e3866512025-07-08
57896-219-01EA - Each57896-219eb48d334-2353-4837-b6bd-a709232bd21612025-05-14
57896-219-05EA - Each57896-2193aefdc12-16ae-4331-b728-3910cc82ff3c12025-05-14
57896-219-10EA - Each57896-2197d69d26f-c56f-42ee-b77f-d8d109fc14ba12025-03-04
57896-219-20EA - Each57896-2195c582850-8a65-4eff-83fa-e8f2e26e5e3112025-02-10
57896-219-50EA - Each57896-21983a1df4a-68d8-425b-8af2-54b7d86361cc12025-06-13

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-887368788-8873-2, 68788-8873-3, 68788-8873-5, 68788-8873-1
57896-219

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.95f4b628-6d35-4f6b-91f9-b2d117f8e8212025-05-16WarningsExact identifier
ndc (package): 68788-8873-3
ndc (package): 68788-8873-5
ndc (package): 68788-8873-1
ndc (package): 68788-8873-2
ndc (product): 68788-8873
ndc11 (package): 68788887301
ndc11 (package): 68788887305
ndc11 (package): 68788887303
ndc11 (package): 68788887302
spl id: 95f4b628-6d35-4f6b-91f9-b2d117f8e821
spl set id: 95f4b628-6d35-4f6b-91f9-b2d117f8e821
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
ndc (product): 57896-219

Reported adverse events (FAERS/openFDA)#

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