Sunmark Arthritis 8 Hour

Manufacturer
Sunmark | Ohm Laboratories Inc.
Effective date
2012-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:47

Label at a glance#

ProductSunmark Arthritis 8 Hour
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: muscular aches headache minor pain of arthritis backache 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 8 hours with water swallow whole - do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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

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 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 overtake 2 caplets every 8 hours with water
    swallow whole - do not crush, chew, split or dissolve
    do not take more than 6 caplets in 24 hours
    do not use for more than 10 days unless directed by a doctor
    children under 12 yearsdo not use

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-406-7984

Keep the carton. It contains important information.

Contains No Aspirin.

Distributed By McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark®

NDC 49348-924-09

See New Warnings Information

Lasts up to 8 hour

8 hour pain relief

Acetaminophen Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

FOR UP TO 8 HOUR RELIEF OF MINOR MUSCULAR ACHES & PAIN

Use only as directed.

50 CAPLETS*650 mg EACH

(*capsule-shaped tablets)

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

†COMPARE TO TYLENOL®8 HOUR ACTIVE INGREDIENT

†This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc. The owner of the registered trademark Tylenol®is The Tylenol Company.

This is the 50 count bottle carton label for Sunmark Acetaminophen extended-release tablets, USP 650 mg.
This is the 50 count bottle carton label for Sunmark Acetaminophen extended-release tablets, USP 650 mg.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN1
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD1
11483998 HR APAP 650 MG Extended Release Oral TabletSY1
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-924-092020-01-31C16284748780-19d75b9d1-0d7d-f424-e053-dadaa90a57ceDrug Facts
49348-924-102020-01-31C16284748780-19d75b9d1-0d7d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-924-09Sunmark Arthritis 8 Hour50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE501
49348-924-10Sunmark Arthritis 8 Hour100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-924SUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1Legacy NDC, 2 package rows20120817_ab6401f9-9310-40dd-8f15-0d7199e27925.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-924-09EA - Each49348-92420bbfe10-c1a5-4644-9fba-a0a4a14cb57e12013-02-13
49348-924-10EA - Each49348-924601fdd47-d845-4143-bbcb-d2c85176eb6f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

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
49348-92449348-924-09, 49348-924-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 6 · 357 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE / ORAL46 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER, FOR SUSPENSION / ORAL64 mgExact identifier — unii candidate
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / BUCCAL5.18 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TROCHE / ORAL50 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii candidate
42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYSTEM / TOPICAL54 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076200-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1984e616aacf4f…
2026-08-18 06:07:402026-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19f41ea6bd6efb…

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
579c5e78-3a1a-4b93-b1ad-3d71d83c91f7ab6401f9-9310-40dd-8f15-0d7199e279252012-08-16WarningsExact identifier
spl id: 579c5e78-3a1a-4b93-b1ad-3d71d83c91f7
spl set id: ab6401f9-9310-40dd-8f15-0d7199e27925

Reported adverse events (FAERS/openFDA)#

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