Storage and handling
Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP
Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP
Active ingredient (in each caplet)
Acetaminophen 650 mg
Purpose
Pain reliever/fever reducer
Uses
For Arthritis Pain
temporarily relieves minor aches and pains due to:
temporarily reduces fever
For Muscle Aches & Pains
temporarily relieves minor aches and pains due to:
temporarily reduces fever
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
Ask a doctor before use if you haveliver disease.
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.
Stop using and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding,ask a health professional before use.
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.
Directions
For Arthritis Pain
Do not take more than directed.See overdose warning
adults:
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:
children under 12 years:do not use
Other information
Inactive ingredientscarnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
Questions or comments?
Call 1-877-290-4008
Relabeled and Repackaged by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 2 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 2 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 2 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 2 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76420-914-01 | Acetaminophen | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 2 | |
| 76420-914-05 | Acetaminophen | 50 in 1 CARTON | TABLET, EXTENDED RELEASE | 50 | 2 | |
| 76420-914-05 | Acetaminophen | 1 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1 | 2 | |
| 76420-914-26 | Acetaminophen | 225 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 225 | 2 | |
| 76420-914-40 | Acetaminophen | 400 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 400 | 2 | |
| 76420-914-42 | Acetaminophen | 24 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 24 | 2 | |
| 76420-914-42 | Acetaminophen | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 2 | |
| 76420-914-60 | Acetaminophen | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76420-914-01 | EA - Each | 76420-914 | 92b7e6de-1e98-43f7-812e-87fd3f5c3b20 | 1 | 2025-07-08 |
| 76420-914-05 | EA - Each | 76420-914 | 33ff1f01-a8fe-41dc-84f0-1252e9805361 | 1 | 2025-07-08 |
| 76420-914-26 | EA - Each | 76420-914 | 49b8b977-285e-4551-9402-4066271cb174 | 1 | 2025-07-08 |
| 76420-914-40 | EA - Each | 76420-914 | 16675aaf-0f63-43d1-9657-9b5e625ea74f | 1 | 2025-07-08 |
| 76420-914-42 | EA - Each | 76420-914 | ca0742f2-4420-4078-9e60-9faf67d0fc50 | 1 | 2025-07-08 |
| 76420-914-60 | EA - Each | 76420-914 | 11addeee-98ff-4849-ab7d-37b1c26c14ca | 1 | 2025-07-08 |
| 49483-699-01 | EA - Each | 49483-699 | 470b7f50-b58f-4173-919b-6286d062799f | 1 | 2022-02-07 |
| 49483-699-05 | EA - Each | 49483-699 | 673efc5f-e4e4-4818-8a11-58de1a0f2750 | 1 | 2022-11-07 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76420-914 | 76420-914-40, 76420-914-01, 76420-914-05, 76420-914-26, 76420-914-42, 76420-914-60 |
| 49483-699 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215486-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215486-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2021-08-25 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN TABLET EXTENDED RELEASE | Asclemed USA, Inc. | 4ef6bc2b-03cf-474f-bb9e-dbb5792ec197 | 2025-02-24 | Warnings | 76420-914-26 76420-914-42 76420-914-05 76420-914-40 76420-914-60 76420-914-01 76420-914 76420091442 76420091460 76420091405 76420091440 76420091401 76420091426 2ef14964-4fa1-9fb6-e063-6294a90aff36 4ef6bc2b-03cf-474f-bb9e-dbb5792ec197 |
| Acetaminophen | ACETAMINOPHEN TABLET EXTENDED RELEASE | TIME CAP LABORATORIES, INC. | cd4d0ad4-7206-94c8-e053-2a95a90aaa14 | 2024-03-19 | Warnings | 49483-699 |
Adverse event summaries are temporarily unavailable. Other product information remains available.