Indications and uses
temporarily relieves minor aches and pains due to: muscular aches minor pain of arthritis backache toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
temporarily relieves minor aches and pains due to: muscular aches minor pain of arthritis backache toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
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 of age: ask a doctor
store between 20-25°C (68-77°F)
Acetaminophen 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 a medical help right away.
liver disease.
taking the blood thinning drug warfarin.
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 (1800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hydroxyethyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose povidone, pregelatinized starch, sodium lauryl sulfate
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
†Compare to the active ingredient of Tylenol® 8HR Muscle Aches & Pain
Extended-release
Pain Reliever
Acetaminophen 650 mg
Pain reliever/Fever reducer
For up to 8 hours relief of minor muscle aches & pain
Caplets*
(*capsule-shaped bi-layer tablets)
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Muscle Aches & Pain.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy Inc
one CVS Drive, Woonsocket RI 02895
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-093 | 69842-093-10, 69842-093-24, 69842-093-15, 69842-093-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | 8136Y38GY5 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A207035-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 |
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 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207035-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2018-05-31 | 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 |
|---|---|---|---|---|---|---|
| 6d2d12fa-f4f2-494e-a20f-e887a56f35c8 | f1f47da9-2002-4bc8-8d26-e66b7b403497 | 2022-11-21 | Warnings | 6d2d12fa-f4f2-494e-a20f-e887a56f35c8 f1f47da9-2002-4bc8-8d26-e66b7b403497 |
Adverse event summaries are temporarily unavailable. Other product information remains available.