FDA.reportPublic FDA data

Acetaminophen

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:36:10

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure17 sections

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

Dosage and administration

■ d o 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)
Acetaminophen USP, 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

■ 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

Liver warning

WARNINGS SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

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

Keep out of reach of children

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ d o 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

Other information

OTHER SAFETY INFORMATION

■ store between 20-25°C (68-77°F)

■ do not use if foil inner seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Pannel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 count100 count50 count50 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN2
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD2
11483998 HR APAP 650 MG Extended Release Oral TabletSY2
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-412-012023-01-30C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-502023-01-30C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-012020-12-30C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-502020-12-30C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-012020-09-27C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-502020-09-27C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-012020-09-25C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-502020-09-25C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-012020-07-22C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain
63868-412-502020-07-22C16284748780-1ab0e2407-2a14-f274-e053-dbdaa90a64718 HOUR Arthritis Pain Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-412-01Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
63868-412-50Acetaminophen50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-412ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]2Legacy NDC, 2 package rows20201231_9f1c8703-0eb2-76f7-e053-2a95a90ac9bb.zip

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
63868-41263868-412-50, 63868-412-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT

Source Document#

Source XML

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
A211544-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16

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 22:38:342026-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16f41ea6bd6efb…

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
b7b520dc-bad0-614f-e053-2995a90ae6779f1c8703-0eb2-76f7-e053-2a95a90ac9bb2020-12-30WarningsExact identifier
spl id: b7b520dc-bad0-614f-e053-2995a90ae677
spl set id: 9f1c8703-0eb2-76f7-e053-2a95a90ac9bb

Reported adverse events (FAERS/openFDA)#

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