Acetaminophen

Manufacturer
CVS Pharmacy
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:47:27

Label at a glance#

ProductAcetaminophen Extended Release
Active ingredientACETAMINOPHEN
Label structure10 sections

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

Dosage and administration

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

Storage and handling

store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

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 ever 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 a medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS HEALTH 8HR Arthritis Pain Relief
CVS HEALTH 8HR Arthritis Pain Relief

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-09369842-093-10, 69842-093-24, 69842-093-15, 69842-093-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207035-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31

Observed Orange Book product history#

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-3184e616aacf4f…
2026-08-18 06:07:402026-07A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31f41ea6bd6efb…

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6d2d12fa-f4f2-494e-a20f-e887a56f35c8f1f47da9-2002-4bc8-8d26-e66b7b4034972022-11-21WarningsExact identifier
spl id: 6d2d12fa-f4f2-494e-a20f-e887a56f35c8
spl set id: f1f47da9-2002-4bc8-8d26-e66b7b403497

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.