Acetaminophen, Dextomethorphan Hydrobromide, Phenylephrine Hydrochloride

FDA Drug Profile — AGRIFEN

Drug Details

Generic Name
Acetaminophen, Dextomethorphan Hydrobromide, Phenylephrine Hydrochloride
Brand Names
AGRIFEN
Application Number
M012
Sponsor
OPMX LLC
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 4 doses in 24 hrs, which is the maximum daily amount for this product. 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 reactions occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor 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 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have Liver disease Hear disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too mcuh plegm (mucus) Persistent or chronic cough occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if You get nervous, dizzy or sleepless Symptoms get worse or last more than 5 days (children) or 7 days (adults) Fever gets worse or lasts more than 3 days Redness or swelling is present New symptoms occur Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition Keep out of reach of children If pregnant or breast-feeding ask a health professional before use. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you dot notice any signs or symptoms.