Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI

FDA Drug Profile — SanaTos Multi Symptom

Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including SanaTos Multi Symptom. Available dosage form: tablet.

Drug Details

Generic Name
Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI
Brand Names
SanaTos Multi Symptom
Application Number
M012
Sponsor
Pharmadel LLC
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (15 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.