Storage and handling
Other information • store at 20-25ºC (68-77ºF) • The FDA approved Dissolution methods differ from USP
Other information • store at 20-25ºC (68-77ºF) • The FDA approved Dissolution methods differ from USP
Active ingredient (in each caplet)
Acetaminophen 650 mg
Purpose
Pain reliever/fever reducer
Uses
• temporarily relieves minor aches and pains due to:
o muscular aches
o backache
o minor pain of arthritis
o toothache
o premenstrual and menstrual cramps
o headache
o the common cold
• temporarily reduces fever
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.
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
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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.
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
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
Other information
• store at 20-25ºC (68-77ºF)
• The FDA approved Dissolution methods differ from USP
Inactive ingredients carnauba 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
| 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 |
|---|---|---|---|---|---|---|
| 55910-895-05 | 8 hr Pain Relief | 1 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1 | 2 | |
| 55910-895-05 | 8 hr Pain Relief | 50 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 50 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55910-895 | 55910-895-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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 |
|---|---|---|---|---|---|---|
| 8 hr Pain Relief | ACETAMINOPHEN | DOLGENCORP, INC. | ea2ebb7b-ceab-567a-e053-2995a90aa402 | 2023-04-20 | Warnings | 55910-895-05 55910-895 55910089505 f9c35f34-c494-2573-e053-6294a90aee3a ea2ebb7b-ceab-567a-e053-2995a90aa402 |