FDA.reportPublic FDA data

Arthritis Pain Reliever

Manufacturer
Lake Erie Medical DBA Quality Care Products LLC
Effective date
2021-02-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:51:36

Label at a glance#

ProductArthritis Pain Reliever
Active ingredientACETAMINOPHEN
Label structure11 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 • 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 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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:
    • 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
  • 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 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

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
North Brunswick, NJ 08902

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-679-302025-01-09C16284748780-1f386c64a-3cd5-0266-e053-dadaa90a7c1aArthritis Pain Relief
55700-679-302023-01-30C16284748780-1f386c64a-3cd5-0266-e053-dadaa90a7c1aArthritis Pain Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-679-30EA - Each55700-6792dc930c3-7848-45ef-8ebf-0cfcd1cb754512018-10-11
51660-333-01EA - Each51660-333bfed0634-d315-412d-8d43-c250141bb6d812012-07-24
51660-333-50EA - Each51660-33303d18899-b4f2-4fb3-abf8-d7d98ce95de512015-10-02

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
55700-67955700-679-30
51660-333

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT

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
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
7bdb0734-45c7-43ed-9815-e7ee441ed17844760aad-bb44-4099-b620-bb5a18c563a12025-01-09WarningsExact identifier
spl set id: 44760aad-bb44-4099-b620-bb5a18c563a1

Reported adverse events (FAERS/openFDA)#

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