FDA.reportPublic FDA data

Tylenol Extra Strength

Manufacturer
Jones Healthcare Group - Packaging Services, Inc
Effective date
2025-07-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:07:00

Label at a glance#

ProductTylenol Extra Strength Caplet
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 menstual cramps • temporarily reduces lever

Dosage and administration

do not take more than directed (see overdose warning).   Adults and children 12 years and over: take 2 capletes every 6 hours while symptoms last do not take more than 6 capletes 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 menstual cramps • temporarily reduces lever

Warnings

WARNINGS SECTION

This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours  Liver warning: 

  • 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 warnings:

SPL UNCLASSIFIED SECTION

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 capletes every 6 hours while symptoms last
  • do not take more than 6 capletes 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 20-25C (68-77F) 
  • 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

PouchPouchLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN7
209459Tylenol Extra Strength 500 MG Oral TabletPSN7
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD7
198440acetaminophen 500 MG Oral TabletSCD7
198440APAP 500 MG Oral TabletSY7
209459APAP 500 MG Oral Tablet [Tylenol]SY7
209459Tylenol 500 MG Oral TabletSY7
209459Tylenol Extra Strength 500 MG Oral TabletSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67414-449-00Tylenol Extra StrengthCaplet2500 in 1 BOXTABLET25007
67414-449-00Tylenol Extra StrengthCaplet2 in 1 POUCHTABLET27
67414-449-10Tylenol Extra StrengthCaplet2 in 1 POUCHTABLET27
67414-449-10Tylenol Extra StrengthCaplet50 in 1 BOXTABLET507
67414-449-11Tylenol Extra StrengthCaplet50 in 1 BOXTABLET507
67414-449-11Tylenol Extra StrengthCaplet2 in 1 POUCHTABLET27

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67414-44967414-449-00, 67414-449-10, 67414-449-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POWDERED CELLULOSESMD1X3XO9MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML · Source PDF

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
Tylenol Extra Strength CapletACETAMINOPHENJones Healthcare Group - Packaging Services, Incfba711c1-4e69-49b0-8994-97c455aebcb22025-07-09WarningsExact identifier
ndc (package): 67414-449-00
ndc (package): 67414-449-11
ndc (package): 67414-449-10
ndc (product): 67414-449
ndc11 (package): 67414044911
ndc11 (package): 67414044910
ndc11 (package): 67414044900
spl id: 39845b60-16e5-ee53-e063-6294a90af9d7
spl set id: fba711c1-4e69-49b0-8994-97c455aebcb2

Reported adverse events (FAERS/openFDA)#

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