Chlorpheniramine maleate, phenylephrine

FDA Drug Profile — Stonarhini

Chlorpheniramine maleate, phenylephrine is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Stonarhini. Available dosage form: tablet.

Drug Details

Generic Name
Chlorpheniramine maleate, phenylephrine
Brand Names
Stonarhini
Application Number
M012
Sponsor
Sato Pharmaceutical Co., Ltd.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms of the common cold ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure

Warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed 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.