SanaTos X

SanaTos X is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI. It is labelled by Pharmadel LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55758-311, application M013, label effective 20231114. 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,GUAIFENESIN, PHENYLEPHRINE HCI are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, pains headache, sore throat, cough due, bronchial irritation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these common cold/ flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes make coughs more productive nasal congestion stuffy nose hay fever temporarily reduces fever

Directions do not take more than directed dosing cup included do not take more than 6 doses in any 24-hour period this product is not intended for use in children under 12 years of age age dose adults & children 12 years of age & over 20 mL every 4 hours 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 6 doses in 24 hours, which is the maximum daily amount take with other drugs containing acetaminophen have 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 an allergic reaction occurs, stop use and seek medical help right away. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician 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 or your child 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 child’s or your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Ask a doctor before use if you have liver disease high blood pressure a cough that is accompanied with excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, bronchitis, or emphysema diffculty in urination due to enlargement of the prostate gland heart disease thyroid disease diabetes Stop use and ask a doctor if skin rash appears symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur These could be signs of a serious condition. If pregnant or breastfeeding, 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.

What is SanaTos X used for?
Uses temporarily relieves these common cold/ flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes make coughs more productive nasal congestion stuffy nose hay fever temporarily reduces fever

Who makes SanaTos X?
Pharmadel LLC is the labeler of record for SanaTos X.

What form does SanaTos X 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 SanaTos X 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 SanaTos X 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.