TYLENOL Acetaminophen Extra Strength

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 20:50:46

Label at a glance#

ProductTYLENOL Acetaminophen 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 20-25°C (68-77°F) do not use if pouch is torn or damaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

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

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 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax 1, corn starch 1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch 1, polyethylene glycol 1, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

1 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)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

Repackaged and distributed by Convenience Valet ®, Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL 2TYLENOL 2TYLENOL®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

2 Pouches of

2 Caplets each

500mg each

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL®

FOR ADULTS
Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

3 Pouches of
2 Caplets each
500 mg each

Tylenol 03Tylenol 03

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

30 Pouches of

2 Caplets each

500 mg each

Do not use if pouch is opened

30 Pouches of 2 Caplets each - 500 mg each

TYLENOL 30 BOXTYLENOL 30 BOX

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

25 Pouches of

2 Caplets each

500 mg each

Do not use if pouch is opened

25 Pouches of 2 Caplets each - 500 mg each

Tylenol 25Tylenol 25

Tylenol ES CVP 4 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

EXTRA STRENGTH

500 mg each

4
Caplets

2 POUCHES OF 2 CAPLETS EACH

CVP

HEALTH

Tylenol ES CVP 4ctTylenol ES CVP 4ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29485-1887-42021-10-14C16284748780-19d75b9d0-9019-f424-e053-dadaa90a57ceTYLENOL ® Acetaminophen Extra Strength
29485-1887-42020-01-31C16284748780-19d75b9d0-9019-f424-e053-dadaa90a57ceTYLENOL ® Acetaminophen Extra Strength

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-1887TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]16Legacy NDC20241101_68bb463c-91af-4eca-b2d5-9d134a756a45.zip
29485-6547TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]16Unmatched20241101_68bb463c-91af-4eca-b2d5-9d134a756a45.zip
29485-6926TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]16Legacy NDC20241101_68bb463c-91af-4eca-b2d5-9d134a756a45.zip
29485-7003TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]16Legacy NDC20241101_68bb463c-91af-4eca-b2d5-9d134a756a45.zip
29485-7025TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED TYLENOL ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]16Legacy NDC20241101_68bb463c-91af-4eca-b2d5-9d134a756a45.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
AcetaminophenACTIVE MOIETY362O9ITL9D1
aluminum oxideINACTIVE INGREDIENTLMI26O69331
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZ1
Castor oilINACTIVE INGREDIENTD5340Y2I9G1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOA1
HypromellosesINACTIVE INGREDIENT3NXW29V3WO1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1A1
Powdered CelluloseINACTIVE INGREDIENTSMD1X3XO9M1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
ShellacINACTIVE INGREDIENT46N107B71O1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A21
Starch, CornINACTIVE INGREDIENTO8232NY3SJ1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 65 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 295 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HypromellosesHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED, EXTENDED RELEASE / ORAL140 mgExact identifier — unii candidate
11 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii candidate
27 equally ranked IID candidates
Powdered CellulosePOWDERED CELLULOSESMD1X3XO9MTABLET / ORAL1582 mgExact identifier — unii candidate
16 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
27 equally ranked IID candidates
Castor oilCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
Powdered CellulosePOWDERED CELLULOSESMD1X3XO9MPOWDER, FOR SUSPENSION / ORAL1600 mgExact identifier — unii candidate
16 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
Powdered CellulosePOWDERED CELLULOSESMD1X3XO9MTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
Powdered CellulosePOWDERED CELLULOSESMD1X3XO9MTABLET, FILM COATED / ORAL392 mgExact identifier — unii candidate
16 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
11 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
ShellacSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C red no. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
25b4a3bd-7f7b-1b3d-e063-6294a90ab4af68bb463c-91af-4eca-b2d5-9d134a756a452024-10-30WarningsExact identifier
spl id: 25b4a3bd-7f7b-1b3d-e063-6294a90ab4af
spl set id: 68bb463c-91af-4eca-b2d5-9d134a756a45

Reported adverse events (FAERS/openFDA)#

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