Pain Relief Regular Strength

ACETAMINOPHEN ORAL HUMAN OTC DRUG

Pain Relief Regular Strength is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Rite Aid Corporation administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260804.

Generic name
ACETAMINOPHEN
Manufacturer
Rite Aid Corporation
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
11822-0104
Application
M013
Label effective
20260804

About this product

Pain Relief Regular Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Rite Aid Corporation taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 11822-0104, application M013, label effective 20260804. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing ACETAMINOPHEN are most often described in connection with: temporarily relieves, minor aches, pains due, common cold, headache backache, pain arthritis, toothache muscular, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each tablet) Acetaminophen 325 mg

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 adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not take for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not take for more than 5 days unless directed by a doctor children under 6 years ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 the user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults redness or swelling is present pain gets worse or lasts more than 5 days in children under 12 years new symptoms occur fever gets worse or lasts more than 3 days 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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How products containing ACETAMINOPHEN compare

FDA lists 274 drug label records with ACETAMINOPHEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Aurohealth LLC 21
— — Genexa Inc. 10
— — Kenvue Brands LLC 9
— — CVS PHARMACY 8
— — Rite Aid Corporation 7

Frequently asked questions

What is Pain Relief Regular Strength used for?
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

Who makes Pain Relief Regular Strength?
Rite Aid Corporation is the labeler of record for Pain Relief Regular Strength. 274 FDA label records share the active ingredient ACETAMINOPHEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pain Relief Regular Strength come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pain Relief Regular Strength prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pain Relief Regular Strength been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.