Drugplain

eight hour pain relief 650 mg/1

Acetaminophen · TABLET, EXTENDED RELEASE · United Natural Foods, Inc. dba UNFI

No Recall HistoryCurrently in Shortage
Plain English

eight hour pain relief is a tablet, extended release containing acetaminophen at 650 mg/1, taken oral. Manufactured by United Natural Foods, Inc. dba UNFI.

Key Facts

Brand Name
eight hour pain relief
Generic Name
Acetaminophen
NDC Code (Product)
41163-203
Manufacturer
United Natural Foods, Inc. dba UNFI
Strength
650 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA211544
Marketing Start
04/29/2022

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
fatigue20,435 reports
drug ineffective18,155 reports
pain18,103 reports
nausea17,623 reports
headache16,714 reports
toxicity to various agents15,539 reports
dyspnoea14,575 reports
arthralgia14,309 reports
pyrexia14,271 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 eight hour pain relief used for?

eight hour pain relief contains Acetaminophen. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is eight hour pain relief a controlled substance?

eight hour pain relief is not classified as a controlled substance by the DEA.

What is the generic name for eight hour pain relief?

The generic name for eight hour pain relief is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for eight hour pain relief 650 mg/1?

The NDC (National Drug Code) for eight hour pain relief 650 mg/1 is 41163-203, listed by United Natural Foods, Inc. dba UNFI.