FDA.reportPublic FDA data

Tylenol Extra Strength

Manufacturer
Navajo Manufacturing Company Inc. | Navajo Manufacutring Company Inc.
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:11:10

Label at a glance#

ProductTylenol Extra Strength
Active ingredientACETAMINOPHEN
Label structure8 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

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 if 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 

OTC - ASK DOCTOR SECTION

if you have disease

Ask a doctor or pharmacist before use 

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are 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

SPL UNCLASSIFIED SECTION

  • store between 20-25°C (68-77°F)
  • see bottom of dispensit for lot number and expiration date
  • do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax*, corn starch*, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
209459Tylenol Extra Strength 500 MG Oral TabletPSN2
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2
209459APAP 500 MG Oral Tablet [Tylenol]SY2
209459Tylenol 500 MG Oral TabletSY2
209459Tylenol Extra Strength 500 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-167-032024-04-17C16284748780-19d75b9cf-e68d-f424-e053-dadaa90a57ceTylenol Extra Strength
67751-167-032020-01-31C16284748780-19d75b9cf-e68d-f424-e053-dadaa90a57ceTylenol Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-167-03Tylenol Extra Strength12 in 1 TRAYTABLET, FILM COATED122
67751-167-03Tylenol Extra Strength2 in 1 POUCHTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-167TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, Legacy NDC, 2 package rows20240418_65bf1556-f25a-9439-e053-2a91aa0a3194.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-449-00EA - Each50580-4496d4b05b4-6ad3-4928-8e25-c8b959463b2d12012-07-24
50580-449-05EA - Each50580-44988acde81-d037-4e5c-bb0c-84fb4f0c8a8712012-07-24
50580-449-07EA - Each50580-44920279d46-6713-4547-84fb-9a08de2e2d1512012-07-24
50580-449-09EA - Each50580-449c71a951e-137e-45aa-9cf4-fcf45d883ade12012-07-24
50580-449-10EA - Each50580-4493e2a7f0e-aa78-48c7-ad46-b671d85aa97912012-07-24
50580-449-12EA - Each50580-449241c2584-6250-4617-9d2b-bea53196e24512014-11-05
50580-449-13EA - Each50580-449e9e4683d-f503-45ba-935a-cfc8788a114a12015-10-02
50580-449-15EA - Each50580-44972f946f0-efd3-40f2-a3f4-b5bb480bb2f512012-07-24
50580-449-23EA - Each50580-449eb924eae-392e-408d-99ad-5b9ccf2f4b1e12012-07-24
50580-449-35EA - Each50580-449ccc5e685-e933-4c54-9a29-4f520edd3cf212013-03-03
50580-449-36EA - Each50580-449fe30c11b-8a2f-49f0-b4f9-7e2c03350a3612013-03-03
50580-449-37EA - Each50580-449d5cb5c35-153e-4f83-b28f-be9370e40ddd12026-04-20
50580-449-61EA - Each50580-449690e1cfe-fa00-469e-9039-75db9bb6375b12023-05-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-16767751-167-03
50580-449

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
FD&C RED NO. 4 FREE ACIDWJE3T5596EIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
ndc (product): 50580-449
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
ndc (product): 67751-167
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.65bf1556-f25a-9439-e053-2a91aa0a31942024-04-15WarningsExact identifier
ndc (package): 67751-167-03
ndc (product): 67751-167
ndc11 (package): 67751016703
spl id: f6f71bb0-5b9b-59f7-e053-6394a90abf8e
spl set id: 65bf1556-f25a-9439-e053-2a91aa0a3194

Reported adverse events (FAERS/openFDA)#

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