ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER

ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS. It is labelled by MEDWISE LIFESCIENCES INC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 87078-331, application M012, label effective 20260515. 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 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough due, minor throat, bronchial irritation, aches pains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Directions take only as directed do not exceed 4 doses per 24 hrs do not give more than directed (see liver warning) follow the instruction given on this carton for your eash use mL=mililiter Age (years) Dose (Sachet) Adults & Children 12 yrs & Over 2 sachets (20 mL*) every 4 hrs Children 6 to under 12 yrs 1 sachet (10 mL*) every 4 hrs Children 4 to under 6 yrs ask a doctor Children under 4 yrs do not use

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (20 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (10 mL each) in 24 hrs, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 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.

What is ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER used for?
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Who makes ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER?
MEDWISE LIFESCIENCES INC. is the labeler of record for ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER.

What form does ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER 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 ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER 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 ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER 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.