Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg

Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL. It is labelled by Softgel Healthcare Private Limited taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 35916-0188, application M012, label effective 20260427. 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.

Across FDA labelling, products containing ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, symptoms due, cold flu, minor aches, pains headache, cough sore, throat nasal, sinus congestion. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •temporarily reduces fever

Directions do not take more than the recommended dose adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. children under 12 years: do not use

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 or severe allergic reactions. Symptoms may include: • skin reddening • blisters • rash • hives • facial swelling • asthma (wheezing) • shock If a skin or general allergic 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.

What is Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg used for?
Uses • temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •temporarily reduces fever

Who makes Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg?
Softgel Healthcare Private Limited is the labeler of record for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg.

What form does Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 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 Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 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.

Has Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 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.