Cold and Flu Relief

Cold and Flu Relief is an FDA-registered drug product whose active ingredient is ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL. It is labelled by CARDINAL HEALTH 110, LLC. DBA LEADER 70000 taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 70000-0515, application M012, label effective 20260909. It is one of 4 FDA drug label records sharing the active ingredient ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL. 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 ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, pains headache, sore throat, nasal congestion, fever sinus. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus pressure cough due to minor throat and bronchial irritation

Directions do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

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. 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 liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage. Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days nervousness, dizziness, or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts 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. Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 4 drug label records with ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 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 Relief used for?
Uses temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus pressure cough due to minor throat and bronchial irritation

Who makes Cold and Flu Relief?
CARDINAL HEALTH 110, LLC. DBA LEADER 70000 is the labeler of record for Cold and Flu Relief. 4 FDA label records share the active ingredient ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, 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 Relief 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 Relief 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 ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?
Yes. 4 FDA drug label records list ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 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 Relief 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.