cough and cold relief HBP

cough and cold relief HBP is an FDA-registered drug product whose active ingredient is CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. It is labelled by United Natural Foods, Inc. dba UNFI taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 41163-698, application M012, label effective 20260804. It is one of 12 FDA drug label records sharing the active ingredient CHLORPHENIRAMINE MALEATE, 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.

Across FDA labelling, products containing CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, runny nose, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold

Directions do not take more than directed adults and children 12 years and over: 1 tablet every 6 hours, not more than 4 tablets in 24 hours children under 12 years: do not use

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland cough that occurs with excessive phlegm (mucus) glaucoma a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 overdose, get medical help or contact a Poison Control Center right away.

FDA lists 12 drug label records with CHLORPHENIRAMINE MALEATE, 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.

What is cough and cold relief HBP used for?
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves runny nose and sneezing due to the common cold

Who makes cough and cold relief HBP?
United Natural Foods, Inc. dba UNFI is the labeler of record for cough and cold relief HBP. 12 FDA label records share the active ingredient CHLORPHENIRAMINE MALEATE, 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 cough and cold relief HBP 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 cough and cold relief HBP 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 CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR?
Yes. 12 FDA drug label records list CHLORPHENIRAMINE MALEATE, 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 cough and cold relief HBP 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.