FDA.reportPublic FDA data

221 Acetaminophen 650MG Tablets, Extended Release

Manufacturer
Medline Industries, LP
Effective date
2026-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-22 03:01:32

Label at a glance#

ProductMedline
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily reliever 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 more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Storage and handling

store at 20-25ºC (68-77ºF) do not use if printed foil under cap is broken or missing ​ meets the requirements of USP Dissolution Test 4

Label contents#

Full prescribing information#

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 reliever 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: 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

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
  • 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 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 20-25ºC (68-77ºF)
  • do not use if printed foil under cap is broken or missing
  • ​meets the requirements of USP Dissolution Test 4

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-MEDLINE (633-5463)

Monday - Friday 7 a.m. to 7 p.m. CST

Manufacturing information

SPL UNCLASSIFIED SECTION

**This product is not manufactured or distributed

by Johnson & Johnson Consumer Inc., McNeil

Consumer Healthcare Division, distributor of

Tylenol® 8HR Arhritis Pain.

www.medline.com ©2026 Medline

Manfuactured for: Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box labelBox label

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-22153329-221-29, 53329-221-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
A075077-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25

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 22:38:342026-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253f01610625f2…
2019-09-15 20:21 UTC2019-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25f41ea6bd6efb…

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 52 · 1,035 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsName fallback
brand name: Medline
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsName fallback
brand name: Medline
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsName fallback
brand name: Medline
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsName fallback
generic name: ACETAMINOPHEN
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsName fallback
generic name: ACETAMINOPHEN
MejoralitoACETAMINOPHENOPMX5a963a92-e29d-05ba-e063-6394a90a3a472026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
PentrexcilinaACETAMINOPHENOPMX LLC5a98e123-8e28-6732-e063-6394a90a010c2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsName fallback
generic name: ACETAMINOPHEN
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsName fallback
generic name: ACETAMINOPHEN
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsName fallback
generic name: ACETAMINOPHEN

Reported adverse events (FAERS/openFDA)#

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