Application 019872

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYLENOLACETAMINOPHENTABLET, EXTENDED RELEASE;ORAL650MGYesYes
002TYLENOLACETAMINOPHENTABLET, EXTENDED RELEASE;ORAL650MGYesYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019872-001TYLENOLACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORALRLD, RS1994-06-08
N019872-002TYLENOLACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORALRLD, RS2001-01-11

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol 8 HR Arthritis PainACETAMINOPHENKenvue Brands LLC3af22fc8-e4e0-4863-8696-6bc1257047cb2024-11-13WarningsExact identifier
Tylenol 8HRACETAMINOPHENKenvue Brands LLC5d7d1300-bcb8-466a-880b-310b360ee1322024-11-07WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 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: 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 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 liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if 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, ask a health professional before use. Keep out of reach of children. 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.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50580-309Tylenol 8HRacetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-309Tylenol 8HRacetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-309Tylenol 8HRacetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-783Tylenol 8 HR Arthritis PainAcetaminophenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57371SUPPL2019-01-29
57370SUPPL2019-01-29
45180SUPPL2016-08-26
34061SUPPL2015-01-05
1746SUPPL2014-12-30
11804SUPPL2014-12-15
1745SUPPL2014-12-15
11803SUPPL2014-03-27
1744SUPPL2014-03-07
34060SUPPL2014-01-09
34059SUPPL2014-01-09
11802SUPPL2014-01-09
1743SUPPL2013-12-26
19787SUPPL2013-03-28
20404SUPPL2012-06-28
41073SUPPL2012-04-13
20405SUPPL2012-01-27
1742SUPPL2012-01-03
1741SUPPL2010-05-17
1740SUPPL2010-05-12
11801SUPPL2009-06-29
1739SUPPL2009-06-23
1738SUPPL2004-11-08
1737SUPPL2004-04-20
19786SUPPL2004-03-30
1736SUPPL2003-08-14
34058SUPPL2003-06-08
34057SUPPL2003-06-08
19785SUPPL2003-06-08
19784SUPPL2003-06-08
11800SUPPL2003-06-08
1735SUPPL2003-06-08