Medique at Home APAP Extra Strength

ACETAMINOPHEN 500 MG ORAL HUMAN OTC DRUG

Medique at Home APAP Extra Strength is an FDA drug label for the active ingredient ACETAMINOPHEN 500 MG manufactured by Sportpharm LLC 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 20260424.

Generic name
ACETAMINOPHEN 500 MG
Manufacturer
Sportpharm LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
85766-126
Application
M013
Label effective
20260424

About this product

Medique at Home APAP Extra Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN 500 MG. It is labelled by Sportpharm LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85766-126, application M013, label effective 20260424. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN 500 MG. 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 500 MG 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 500 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 use more than directed (see overdose warning) Adults and children 12 years and over ■ take 2 tablets every 6 hours while symptoms last. ■ do not take more than 6 tablets 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.

More products with the same ingredient

ACETAMINOPHEN 500 MG

Extra Strength Pain Reliever mini softgels

Shield Pharmaceuticals Corp View label

Pain Relief Extra Strength

Allegiant Health View label

How products containing ACETAMINOPHEN 500 MG compare

FDA lists 3 drug label records with ACETAMINOPHEN 500 MG 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
— — Allegiant Health 1
— — Shield Pharmaceuticals Corp 1
— — Sportpharm LLC 1
— — — —
— — — —

Frequently asked questions

What is Medique at Home APAP Extra 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 Medique at Home APAP Extra Strength?
Sportpharm LLC is the labeler of record for Medique at Home APAP Extra Strength. 3 FDA label records share the active ingredient ACETAMINOPHEN 500 MG, 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 Medique at Home APAP Extra 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 Medique at Home APAP Extra 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 500 MG?
Yes. 3 FDA drug label records list ACETAMINOPHEN 500 MG 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 Medique at Home APAP Extra 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.