Timely 699R 704R Acetaminophen Extended-Release Tablets USP, 650 mg

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2025-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:03

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections

Storage and handling

Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 650 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

For Arthritis Pain

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

For Muscle Aches & Pains

temporarily relieves minor aches and pains due to:

  • muscular aches
  • backache
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps
  • headache
  • the common cold

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 haveliver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

OTC - STOP USE SECTION

Stop using 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.

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

For Arthritis Pain

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

For Muscle Aches & Pains

Do not take more than directed.See overdose warning

adults and children 12 years and over:

  • 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

children under 12 years:do not use

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Questions or comments?

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relabeled and Repackaged by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

labellabel

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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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79e1734e-f721-4d46-978a-be382f771672Product name220230110
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-914-01Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
76420-914-05Acetaminophen50 in 1 CARTONTABLET, EXTENDED RELEASE502
76420-914-05Acetaminophen1 in 1 BOTTLETABLET, EXTENDED RELEASE12
76420-914-26Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2252
76420-914-40Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4002
76420-914-42Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE242
76420-914-42Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE12
76420-914-60Acetaminophen60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-914ACETAMINOPHEN (ACETAMINOPHEN TABLET EXTENDED RELEASE) TABLET, EXTENDED RELEASE [ASCLEMED USA, INC.]2Current NDC, 8 package rows20250227_4ef6bc2b-03cf-474f-bb9e-dbb5792ec197.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-914-01EA - Each76420-91492b7e6de-1e98-43f7-812e-87fd3f5c3b2012025-07-08
76420-914-05EA - Each76420-91433ff1f01-a8fe-41dc-84f0-1252e980536112025-07-08
76420-914-26EA - Each76420-91449b8b977-285e-4551-9402-4066271cb17412025-07-08
76420-914-40EA - Each76420-91416675aaf-0f63-43d1-9657-9b5e625ea74f12025-07-08
76420-914-42EA - Each76420-914ca0742f2-4420-4078-9e60-9faf67d0fc5012025-07-08
76420-914-60EA - Each76420-91411addeee-98ff-4849-ab7d-37b1c26c14ca12025-07-08
49483-699-01EA - Each49483-699470b7f50-b58f-4173-919b-6286d062799f12022-02-07
49483-699-05EA - Each49483-699673efc5f-e4e4-4818-8a11-58de1a0f275012022-11-07

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
76420-91476420-914-40, 76420-914-01, 76420-914-05, 76420-914-26, 76420-914-42, 76420-914-60
49483-699

Ingredients#

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

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHEN TABLET EXTENDED RELEASEAsclemed USA, Inc.4ef6bc2b-03cf-474f-bb9e-dbb5792ec1972025-02-24WarningsExact identifier
ndc (package): 76420-914-26
ndc (package): 76420-914-42
ndc (package): 76420-914-05
ndc (package): 76420-914-40
ndc (package): 76420-914-60
ndc (package): 76420-914-01
ndc (product): 76420-914
ndc11 (package): 76420091442
ndc11 (package): 76420091460
ndc11 (package): 76420091405
ndc11 (package): 76420091440
ndc11 (package): 76420091401
ndc11 (package): 76420091426
spl id: 2ef14964-4fa1-9fb6-e063-6294a90aff36
spl set id: 4ef6bc2b-03cf-474f-bb9e-dbb5792ec197
AcetaminophenACETAMINOPHEN TABLET EXTENDED RELEASETIME CAP LABORATORIES, INC.cd4d0ad4-7206-94c8-e053-2a95a90aaa142024-03-19WarningsExact identifier
ndc (product): 49483-699

Reported adverse events (FAERS/openFDA)#

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