For Arthritis Pain label • 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 & Pain label • temporarily relieves minor aches and pains due to: • muscular aches • backache • minor pain of arthritis ...
For Arthritis Pain Label • 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 Ache and Pain label • do not take more than directed (see overdos...
Acetaminophen USP, 650 mg
Pain reliever/fever reducer
For
Arthritis Pain label
• 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 & Pain label
• 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
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 everyday 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
• with any other drugs 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.
liver disease.
taking the blood thinning drug warfarin.
• 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.
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
For Arthritis Pain Label
•
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 Ache and Pain label
• do not take more than directed (see overdose warning)
| adults and children
12 years of age 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 |
• store between 20-25°C (68-77°F)
• do not use if foil inner seal is broken or missing.
hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Contact 1-844-384-3723 Mon-Fri 8:00 AM EST to 5:00 PM PST.
100 Count
400 Count
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 1 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 1 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 1 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 1 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71309-011-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-448e-111a-e063-dadaa90a10e2 | Acetaminophen Extended Release Tablets 650 mg |
| 71309-011-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-448e-111a-e063-dadaa90a10e2 | Acetaminophen Extended Release Tablets 650 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71309-011-04 | ACETAMINOPHEN | 400 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 400 | 1 | |
| 71309-011-10 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71309-011 | 71309-011-10, 71309-011-04 |
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 |
|---|---|---|---|---|---|---|---|
| A211544-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 |
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 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211544-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2019-04-16 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| df49f634-daed-735d-e053-2995a90a7e2b | df49f634-daec-735d-e053-2995a90a7e2b | 2022-05-18 | Warnings | df49f634-daed-735d-e053-2995a90a7e2b df49f634-daec-735d-e053-2995a90a7e2b |
Adverse event summaries are temporarily unavailable. Other product information remains available.