Drugplain

Pain Relief 325 mg/1

Acetaminophen · TABLET · HYVEE INC

10 Recalls on RecordCurrently in Shortage
Plain English

Acetaminophen is an over-the-counter pain reliever and fever reducer available in 325 mg tablets that you take by mouth. It's commonly used to treat mild to moderate pain and reduce fever.

Key Facts

Brand Name
Pain Relief
Generic Name
Acetaminophen
NDC Code (Product)
42507-501
Manufacturer
HYVEE INC
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
10/22/2025

Recall History

10 Recalls on Record
Class II08/09/2019

Ridge Properties, LLC

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated
Class II11/03/2017

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

TerminatedVoluntary: Firm initiated
Class II08/09/2019

Ridge Properties, LLC

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated
Class II08/11/2023

AVKARE LLC

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

TerminatedVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class II09/17/2015

The Mentholatum Co.

Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section

TerminatedVoluntary: Firm initiated
Class II11/03/2017

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

TerminatedVoluntary: Firm initiated
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class III08/03/2020

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective64,831 reports
fatigue63,374 reports
nausea54,982 reports
off label use50,228 reports
pain49,733 reports
dyspnoea48,472 reports
diarrhoea46,576 reports
headache45,591 reports
dizziness38,980 reports
vomiting37,643 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last 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 ask a doctor

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 medica

Frequently Asked Questions

What is Pain Relief used for?

Acetaminophen is an over-the-counter pain reliever and fever reducer available in 325 mg tablets that you take by mouth. It's commonly used to treat mild to moderate pain and reduce fever.

Is Pain Relief a controlled substance?

Pain Relief is not classified as a controlled substance by the DEA.

What is the generic name for Pain Relief?

The generic name for Pain Relief is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Pain Relief 325 mg/1?

The NDC (National Drug Code) for Pain Relief 325 mg/1 is 42507-501, listed by HYVEE INC.