FDA.reportPublic FDA data

PANADOL

Manufacturer
Haleon US Holdings LLC
Effective date
2024-02-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:08:21

Label at a glance#

ProductPANADOL Extra Strength
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache backache muscular aches minor arthritis pain temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor do not take more than 8 caplets in 24 hours, unless directed by a doctor children under 12 years of age: ask a doctor

Storage and handling

store below 25°C (77°F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • muscular aches
    • minor arthritis pain
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:A‑cetaminophen 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 a 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
  • redness or swelling is present
  • any new symptoms appear

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:

OVERDOSAGE SECTION

Taking more than the recommended dose can cause serious health problems. 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(see overdose warning)
  • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
  • do not take more than 8 caplets in 24 hours, unless directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store below 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-455-7139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0609-01

PANADOL

EXTRA STRENGTH

500

ACETAMINOPHEN

Pain Reliever

Fever Reducer

24 CAPLETS

Trademarks are owned by or licensed to the GSK group of companies.

Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Distributed by:

GSKConsumer Healthcare, Warren, NJ 07059

©2016 GSK group of companies or its licensor.

101596D

101596XD_Panadol Extra Strength 500_24 ct.JPG
101596XD_Panadol Extra Strength 500_24 ct.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN7
200977Panadol Extra Strength 500 MG Oral TabletPSN7
200977acetaminophen 500 MG Oral Tablet [Panadol]SBD7
198440acetaminophen 500 MG Oral TabletSCD7
198440APAP 500 MG Oral TabletSY7
200977APAP 500 MG Oral Tablet [Panadol]SY7
200977Panadol 500 MG Oral TabletSY7
200977Panadol Extra Strength 500 MG Oral TabletSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0609-012020-07-22C16284748780-1ab0e2407-355a-f274-e053-dbdaa90a6471Drug Facts
0135-0609-022020-07-22C16284748780-1ab0e2407-355a-f274-e053-dbdaa90a6471Drug Facts
0135-0609-032020-07-22C16284748780-1ab0e2407-355a-f274-e053-dbdaa90a6471Drug Facts
0135-0609-042020-07-22C16284748780-1ab0e2407-355a-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0609-01PANADOLExtra Strength24 in 1 BOTTLETABLET, FILM COATED247
0135-0609-01PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
0135-0609-02PANADOLExtra Strength50 in 1 BOTTLETABLET, FILM COATED507
0135-0609-02PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
0135-0609-03PANADOLExtra Strength100 in 1 BOTTLETABLET, FILM COATED1007
0135-0609-03PANADOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
0135-0609-04PANADOLExtra Strength50 in 1 CARTONTABLET, FILM COATED507
0135-0609-05PANADOLExtra Strength2 in 1 PACKETTABLET, FILM COATED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0609PANADOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 8 package rows20240207_b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0609-01EA - Each0135-0609fe1f0735-9843-4fe3-bb42-0a2256c3b2c612022-12-07
0135-0609-02EA - Each0135-06092e35bea5-0a22-4410-ac97-e2465812c2d812022-12-07
0135-0609-03EA - Each0135-0609a22d623d-3cc7-4af6-a98a-fbe4fceff39012022-12-07

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
0135-06090135-0609-01, 0135-0609-02, 0135-0609-03, 0135-0609-05, 0135-0609-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
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
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
ndc (package): 0135-0609-01
ndc (package): 0135-0609-02
ndc (package): 0135-0609-04
ndc (package): 0135-0609-05
ndc (package): 0135-0609-03
ndc (product): 0135-0609
ndc11 (package): 00135060905
ndc11 (package): 00135060904
ndc11 (package): 00135060903
ndc11 (package): 00135060901
ndc11 (package): 00135060902
spl id: 10c10ae1-2b66-f708-e063-6394a90a0fca
spl set id: b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b

Reported adverse events (FAERS/openFDA)#

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