Maximum Strength Multi-Symptom Relief

ACETAMINOPHEN, DEXTROMETHORPHAN HBR ORAL HUMAN OTC DRUG

Maximum Strength Multi-Symptom Relief is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR manufactured by KROGER COMPANY 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 20260619.

Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR
Manufacturer
KROGER COMPANY
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
41226-674
Application
M012
Label effective
20260619

About this product

Maximum Strength Multi-Symptom Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR. It is labelled by KROGER COMPANY taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 41226-674, application M012, label effective 20260619. It is one of 15 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR. 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, DEXTROMETHORPHAN HBR are most often described in connection with: common cold, temporarily relieves, flu symptoms, cough due, minor throat, bronchial irritation, inhaled irritants, intensity coughing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep - minor aches and pains - sore throat - headache temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and over: take 2 caplets every 4 hours children under 12 years of age: do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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ACETAMINOPHEN, DEXTROMETHORPHAN HBR

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How products containing ACETAMINOPHEN, DEXTROMETHORPHAN HBR compare

FDA lists 15 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR 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
— — CVS PHARMACY 3
— — AMERISOURCE BERGEN 1
— — CARDINAL HEALTH 110, LLC. DBA LEADER 1
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1
— — Genexa Inc. 1

Frequently asked questions

What is Maximum Strength Multi-Symptom Relief used for?
Uses temporarily relieves these common cold and flu symptoms: - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep - minor aches and pains - sore throat - headache temporarily reduces fever

Who makes Maximum Strength Multi-Symptom Relief?
KROGER COMPANY is the labeler of record for Maximum Strength Multi-Symptom Relief. 15 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 Maximum Strength Multi-Symptom Relief 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 Maximum Strength Multi-Symptom Relief 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, DEXTROMETHORPHAN HBR?
Yes. 15 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR 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 Maximum Strength Multi-Symptom Relief 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.