Extra Strenghth Acetaminophen

Manufacturer
OPMX LLC | Health Pharma USA LLC
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:30

Label at a glance#

ProductExtra Strenghth Acetaminophen
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

do not use more than directed (see overdose warning) Adults and children 12 years of age and older: 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 more than 10 days unless directed by a doctor. Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporary relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • temporarily reduces fever
  • premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3000 mg) in 24 hours. 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

  • 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

  • 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 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:Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (1-800-222-1222) 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 use more than directed (see overdose warning)

Adults and children 12 years of age and older:

  • 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 more than 10 days unless directed by a doctor.

Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 20-25°C (68-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, pregelatinized starch, povidone (pvp k-30), croscarmellose sodium, potassium sorbate, stearic acid

Questions or Comments

OTC - QUESTIONS SECTION

Call 619-600-5632 Monday through Friday 9AM-5PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TempxbTempxb

TempxaTempxa

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN5
198440acetaminophen 500 MG Oral TabletSCD5
198440APAP 500 MG Oral TabletSY5

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-107-40Extra Strenghth Acetaminophen1 in 1 CARTONTABLET15
69729-107-40Extra Strenghth Acetaminophen40 in 1 BOTTLETABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-107EXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [OPMX LLC]5Legacy NDC, 2 package rows20250322_ae6dae28-6f4f-16d1-e053-2995a90adbab.zip

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
69729-10769729-107-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
30b6aac4-6c66-45db-e063-6394a90aa5c5ae6dae28-6f4f-16d1-e053-2995a90adbab2025-03-19WarningsExact identifier
spl id: 30b6aac4-6c66-45db-e063-6394a90aa5c5
spl set id: ae6dae28-6f4f-16d1-e053-2995a90adbab

Reported adverse events (FAERS/openFDA)#

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