FDA.reportPublic FDA data

CARDINAL-LEADER Acetaminophen Extended-Release Tablets USP, 650 mg

Manufacturer
LEADER/ Cardinal Health 110, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-06-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:43

Label at a glance#

Product8HR Arthritis Pain Relief
Active ingredientACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 650 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/ fever reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:

- minor pain of arthritis
- muscular aches n backache
- premenstrual and menstrual cramps

- the common cold n headache
- toothache

  • temporarily reduces fever

WARNINGS SECTION

Warnings


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.

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

OVERDOSAGE 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.

DOSAGE & ADMINISTRATION SECTION

Directions 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

OTHER SAFETY INFORMATION

Other information

  • store between 20-25°C (68-77°F)
  • The FDA approved dissolution methods differ from USP

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

apap-50s-labelapap-50s-labelapap-50s-ifcapap-50s-ifclc-apap-label-100slc-apap-label-100slc-apap-ifc-100slc-apap-ifc-100s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN3
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD3
11483998 HR APAP 650 MG Extended Release Oral TabletSY3
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0733-18HR Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE13
70000-0733-18HR Arthritis Pain Relief100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
70000-0733-28HR Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE13
70000-0733-28HR Arthritis Pain Relief50 in 1 BOTTLETABLET, EXTENDED RELEASE503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0733-1EA - Each70000-0733c4f05c4d-12e8-40ce-8611-1d1abb3fe17812026-02-05

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
70000-073370000-0733-1, 70000-0733-2

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)8136Y38GY5IACT
MAGNESIUM STEARATE70097M6I30IACT
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT

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
8HR Arthritis Pain ReliefACETAMINOPHENLEADER/ Cardinal Health 110, Inc.331f907a-0fb6-e23d-e063-6394a90a2db12025-06-22WarningsExact identifier
ndc (package): 70000-0733-1
ndc (package): 70000-0733-2
ndc (product): 70000-0733
ndc11 (package): 70000073302
ndc11 (package): 70000073301
spl id: 383635e0-836f-50c8-e063-6394a90a28bf
spl set id: 331f907a-0fb6-e23d-e063-6394a90a2db1

Reported adverse events (FAERS/openFDA)#

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