FDA.reportPublic FDA data

Acetaminophen Extra Strength

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:53

Label at a glance#

ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure15 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 between 20° to 25°C (68° to 77°F) do not use if printed foil seal under cap is torn or missing.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen USP 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 are allergic to acetaminophen or any of the inactive ingredients in this product

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 between 20° to 25°C (68° to 77°F)
  • do not use if printed foil seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch (maize), stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC.
279 Princeton- Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-776-88Primary Health

Compare to the active ingredient in
Tylenol ® Extra strength Caplets *  

See New Warnings Information & Directions
EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen Caplets 500 mg
Pain reliever/Fever reducer
N 79

750 CAPLETS
500 mg each
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-776-88Acetaminophen Extra Strength750 in 1 BOTTLETABLET7502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-776ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AUROHEALTH LLC]2Current NDC, Legacy NDC, 1 package rows20231130_57bb1acc-b9a0-48cd-8e5c-33712441ce81.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-77658602-776-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
PALMITOSTEARIC ACIDQ8Y7S3B85MIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLC57bb1acc-b9a0-48cd-8e5c-33712441ce812023-11-29WarningsExact identifier
ndc (package): 58602-776-88
ndc (product): 58602-776
ndc11 (package): 58602077688
spl id: 0b4541a6-ce74-d7e6-e063-6294a90aa709
spl set id: 57bb1acc-b9a0-48cd-8e5c-33712441ce81

Reported adverse events (FAERS/openFDA)#

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