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 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3
Active ingredient (in each extended-release tablet)
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.
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
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.
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
Questions or comments?
call 1-855-274-4122
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, Rl 02895
©2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
Code: TS/DRUGS/22/2009
♥CVS
Health®
Compare to the active ingredient
in Tylenol® 8HR Arthritis Pain*
Tablets
NDC 69842-037-35
8HR Arthritis
Pain Relief
ACETAMINOPHEN
EXTENDED-RELEASE TABLETS,
USP 650 mg
Pain Reliever/Fever Reducer
For the temporary relief of
minor arthritis pain
Actual
Size
TO OPEN:
1. PUSH DOWN
2. TURN CAP
225 EXTENDED-
RELEASE TABLETS
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 8 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 8 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 8 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 8 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-037-35 | Acetaminophen | 225 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 225 | 8 | |
| 69842-037-44 | Acetaminophen | 400 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 400 | 8 | |
| 69842-037-91 | Acetaminophen | 150 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 150 | 8 | |
| 69842-037-91 | Acetaminophen | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 8 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69842-037-35 | EA - Each | 69842-037 | 34b9136e-6188-40fa-a005-bf8d45d14b2e | 1 | 2023-01-09 |
| 69842-037-44 | EA - Each | 69842-037 | 2f0ab66e-ea07-4f74-b8c0-703e30a1b5ca | 1 | 2023-01-09 |
| 69842-037-91 | EA - Each | 69842-037 | af7034d9-fb99-4d6a-a71e-6816aa7067a5 | 1 | 2023-01-09 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-037 | 69842-037-91, 69842-037-35, 69842-037-44 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207229-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2016-11-09 | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc. | b70beee4-407e-547c-e053-2a95a90af22a | 2024-01-24 | Warnings | 69842-037-35 69842-037-91 69842-037-44 69842-037 69842003744 69842003735 69842003791 3ac76330-16d2-44f6-b013-8683059b83a9 b70beee4-407e-547c-e053-2a95a90af22a |
Adverse event summaries are temporarily unavailable. Other product information remains available.