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8HR Muscle Aches and Pain

Acetaminophen · Tablet, Extended Release

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
8HR Muscle Aches and Pain
Generic name
Acetaminophen
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
AAA Pharmaceutical, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Acetaminophen 650 mg/1 313782 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211544
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 16, 2019
Sponsor
GRANULES
Products on application
1
Submissions recorded
2
Products approved under application 211544.
Product Trade name Form Strength Ingredient Status TE Flags
211544-001 ACETAMINOPHEN TABLET, EXTENDED RELEASE ACETAMINOPHEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 211544.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20240613

Indications and Usage

openFDA Drug Labeling

Uses 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 Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions 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 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 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 Labeling

Ask a doctor before use if you have liver disease

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.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each caplet) Acetaminophen 650 mg

Adverse event reports

Source: openFDA FAERS
679,519
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.