Kids Multi Symptom Cold and Flu

Kids Multi Symptom Cold and Flu is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR. It is labelled by Genexa Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69676-0096, application M012, label effective 20260528. 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.

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

Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches & pains headache cough due to minor throat and bronchial irritation sore throat controls the impulse to cough to help your child get to sleep

Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) SHAKE WELL BEFORE EACH USE find right dose on chart below for accurate dosing, use measuring cup provided. Do not use with any other dosing device. give dose every 4 hours while symptoms last do not give more than 5 times in 24 hours children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 7.5 mL every 4 hours children under 4 years do not use

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

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.

What is Kids Multi Symptom Cold and Flu used for?
Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches & pains headache cough due to minor throat and bronchial irritation sore throat controls the impulse to cough to help your child get to sleep

Who makes Kids Multi Symptom Cold and Flu?
Genexa Inc. is the labeler of record for Kids Multi Symptom Cold and Flu. 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 Kids Multi Symptom Cold and Flu 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 Kids Multi Symptom Cold and Flu 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 Kids Multi Symptom Cold and Flu 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.