Phenylephrine HCl 10 mg

FDA Drug Profile — Nasal Decongestant PE

Drug Details

Generic Name
Phenylephrine HCl 10 mg
Brand Names
Nasal Decongestant PE
Application Number
M012
Sponsor
NUVICARE LLC
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■ minor aches and pains ■ sore throat ■ headache ■ stuffy nose ■ sinus congestion and pressure ■ temporarily reduces fever ■ 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 you take: ■ more than 6 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily 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.