Cold and Flu HBP

Cold and Flu HBP is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE. It is labelled by Kroger Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 30142-698, application M012, label effective 20260910. It is one of 5 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE. 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, CHLORPHENIRAMINE MALEATE are most often described in connection with: temporarily relieves, symptoms due, cold flu, headache sneezing, runny nose, minor aches, pains sore, reduces fever. 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: headache sneezing runny nose minor aches and pains sore throat temporarily reduces fever

Directions do not take more than directed adults and children 12 years and over: take 2 tablets with water every 4-6 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor. children under 12 years of age: 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 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. 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. Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product excitability may occur, especially in children 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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 5 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE 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 Cold and Flu HBP used for?
Uses temporarily relieves these symptoms due to a cold or flu: headache sneezing runny nose minor aches and pains sore throat temporarily reduces fever

Who makes Cold and Flu HBP?
Kroger Company is the labeler of record for Cold and Flu HBP. 5 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, 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 Cold and Flu 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 Cold and Flu 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 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE?
Yes. 5 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE 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 Cold and Flu 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.