8HR Arthritis Pain 650 mg/1

Acetaminophen · TABLET, EXTENDED RELEASE · FSA STORE INC.

No Recall HistoryCurrently in Shortage

Plain English

8HR Arthritis Pain is a tablet, extended release containing acetaminophen at 650 mg/1, taken oral. Manufactured by FSA STORE INC..

Key Facts

Brand Name: 8HR Arthritis Pain
Generic Name: Acetaminophen
NDC Code (Product): 81522-200
Manufacturer: FSA STORE INC.
Strength: 650 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA211544
Marketing Start: 11/16/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports

fatigue20,446 reports

drug ineffective18,155 reports

pain18,110 reports

nausea17,641 reports

headache16,728 reports

toxicity to various agents15,538 reports

dyspnoea14,589 reports

arthralgia14,309 reports

pyrexia14,277 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

Directions do 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, unless directed by a doctor do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Warnings

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 ov…

Frequently Asked Questions

What is 8HR Arthritis Pain used for?

8HR Arthritis Pain contains Acetaminophen. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is 8HR Arthritis Pain a controlled substance?

8HR Arthritis Pain is not classified as a controlled substance by the DEA.

What is the generic name for 8HR Arthritis Pain?

The generic name for 8HR Arthritis Pain is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for 8HR Arthritis Pain 650 mg/1?

The NDC (National Drug Code) for 8HR Arthritis Pain 650 mg/1 is 81522-200, listed by FSA STORE INC..

Product NDC

81522-200

Package NDC

81522-200-03

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)