dextromethorphan hydrobromide
dextromethorphan hydrobromide is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including ROBITUSSIN LONG-ACTING COUGHGELS, ROBITUSSIN LONG-ACTING COUGH Soft CHEWS, Robitussin Direct Cough. Available dosage forms: capsule, liquid filled, tablet, chewable, lozenge, liquid.
Drug Details
- Generic Name
- dextromethorphan hydrobromide
- Brand Names
- ROBITUSSIN LONG-ACTING COUGHGELS, ROBITUSSIN LONG-ACTING COUGH Soft CHEWS, Robitussin Direct Cough, Stona, Childrens Robitussin Cough Long-Acting
- Application Number
- M012
- Sponsor
- Haleon US Holdings LLC
- NDC Codes
- 7
- Dosage Forms
- CAPSULE, LIQUID FILLED, TABLET, CHEWABLE, LOZENGE, LIQUID
- Routes
- ORAL
- Active Ingredients
- DEXTROMETHORPHAN HYDROBROMIDE
Indications and Usage
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
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.
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.