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
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
do not take more than directed (see overdose warning). Adults: take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor. Under 18 years of age: ask a doctor
store at 20º to 25ºC (68º to 77ºF). Avoid excessive heat 40ºC (104ºF) do not use if carton is opened or foil inner seal is broken USP Dissolution test is pending
Drug Facts
Acetaminophen USP 650 mg
Pain reliever/fever reducer
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.
whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before ue if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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.
do not take more than directed (see overdose warning).
Adults:
Under 18 years of age:
colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin
call 1-855-274-4122
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India.
For BluePoint Laboratories
Rev: 03/2021
M.L. No.: 22/MN/AP/2009/F/R
Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00
Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 3 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 3 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 3 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 3 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-495-00 | Acetaminophen | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 68001-495-00 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-495-00 | EA - Each | 68001-495 | 83c3754a-4353-4a7b-8c71-91f6b2403cbb | 1 | 2021-06-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68001-495 | 68001-495-00 |
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 |
|---|---|---|---|---|---|---|---|
| A207229-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 3a93d1ddd44b… |
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 | BluePoint Laboratories | c065c531-88f5-0930-e053-2a95a90ae861 | 2024-06-05 | Warnings | 68001-495-00 68001-495 68001049500 1a273bc1-09a5-3877-e063-6394a90a9388 c065c531-88f5-0930-e053-2a95a90ae861 |
Adverse event summaries are temporarily unavailable. Other product information remains available.