FDA.reportPublic FDA data

Arthritis Pain Relief

Manufacturer
WINCO FOODS, LLC
Effective date
2023-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:42

Label at a glance#

ProductArthritis Pain Relief
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning ) adults 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Storage and handling

store between 20-25°C (68-77°F) retain carton for complete product information and warnings

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
  • 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 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

SPL UNCLASSIFIED SECTION

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
  • 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, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
under 18 years of age
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • retain carton for complete product information and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

OTC - QUESTIONS SECTION

Call 800-824-1706 Monday - Friday  9am - 4pm MST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WinCo® Foods

8-HOUR

Arthritis Pain Relief

ACETAMINOPHEN

Extended-Release Tablets, 650 mg

Pain Reliever/Fever Reducer

*Compare to the active ingredient in TYLENOL® 8HR Arthritis Pain

For the Temporary Relief of Minor Arthritis Pain

Lasts up to 8 Hours

50 Caplets** 650 MG Each

**Capsule-Shaped Bi-Layer Tablets

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN2
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD2
11483998 HR APAP 650 MG Extended Release Oral TabletSY2
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-401-02Arthritis Pain Relief50 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE502
67091-401-02Arthritis Pain Relief2 in 1 CARTONTABLET, EXTENDED RELEASE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-401ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [WINCO FOODS, LLC]2Current NDC, 2 package rows20230412_f45f43da-b994-2bc8-e053-2995a90a93e0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-40167091-401-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

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
A211544-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16

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 22:38:342026-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16f41ea6bd6efb…

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
Arthritis Pain ReliefACETAMINOPHENWINCO FOODS, LLCf45f43da-b994-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
ndc (package): 67091-401-02
ndc (product): 67091-401
ndc11 (package): 67091040102
spl id: f9159d83-e662-0576-e053-6394a90a651a
spl set id: f45f43da-b994-2bc8-e053-2995a90a93e0

Reported adverse events (FAERS/openFDA)#

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