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8HR Muscle Aches and Pain
Acetaminophen · Tablet, Extended Release
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Acetaminophen | 650 mg/1 | 313782 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 211544-001 | ACETAMINOPHEN | TABLET, EXTENDED RELEASE | ACETAMINOPHEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 16 | Labeling | Approved | January 18, 2024 | Standard |
| Original application | 1 | Approved | April 16, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240613). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
Purpose
openFDA Drug LabelingPurpose Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years do not use
Warnings
openFDA Drug LabelingWarnings 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.
Do Not Use
openFDA Drug LabelingDo 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
openFDA Drug LabelingAsk a doctor before use if you have liver disease
Stop Use
openFDA Drug LabelingStop 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.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each caplet) Acetaminophen 650 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 57344-201-03 | 57344-201 | AAA Pharmaceutical, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (57344-201-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | April 15, 2024 |
| 81522-201-03 | 81522-201 | FSA STORE INC. | 1 BOTTLE, PLASTIC in 1 CARTON (81522-201-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | March 20, 2024 |
| 57344-201 | 57344-201 | AAA Pharmaceutical, Inc. | — | April 15, 2024 |
| 81522-201 | 81522-201 | FSA STORE INC. | — | March 20, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 9 sections on this page.