FDA.reportPublic FDA data

Sams Club Acetaminophen Extended Release Tablets USP 650 mg

Manufacturer
SAM'S WEST INC | TIME CAP LABORATORIES,INC | MARKSANS PHARMA LIMITED
Effective date
2025-08-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:05

Label at a glance#

ProductArthritis Pain
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 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 20-25ºC (68-77ºF) The FDA approved dissolution methods differ from USP

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

-

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: 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,

PREGNANCY 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 for more than 10 days unless directed by a doctor
under 18 years of age

ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25ºC (68-77ºF)
  • The FDA approved dissolution methods differ from USP

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-290-4008
9:00 AM-5:00 PM ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-200s-label-200s-

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-034-02Arthritis Pain200 in 1 BOTTLETABLET, EXTENDED RELEASE2002

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
68196-03468196-034-02

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
CARNAUBA WAXR12CBM0EIZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MAGNESIUM STEARATE70097M6I30IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
TRIACETINXHX3C3X673IACT
HYPROMELLOSES3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT

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
A215486-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2584e616aacf4f…
2026-08-18 06:07:402026-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25a50c72e98297…

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 PainACETAMINOPHENSAM'S WEST INC3928090d-b45e-6948-e063-6394a90a47dd2025-08-11WarningsExact identifier
ndc (package): 68196-034-02
ndc (product): 68196-034
ndc11 (package): 68196003402
spl id: 3c156540-3319-441d-e063-6394a90adced
spl set id: 3928090d-b45e-6948-e063-6394a90a47dd

Reported adverse events (FAERS/openFDA)#

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