Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
Drug Details
- Generic Name
- Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
- Brand Names
- Dr. Simi Daytime Cold and Flu
- Application Number
- M012
- Sponsor
- Shield Pharmaceuticals Corp
- NDC Codes
- 2
- Dosage Forms
- CAPSULE, LIQUID FILLED
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, DEXTROAMPHETAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Indications and Usage
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 softgels 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 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. 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 • thyroid disease • high blood pressure • trouble urinating due to enlarged prostate gland • heart disease • diabetes • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma 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 • pain, cough, or nasal congestion gets worse or lasts more than 7 days • nervousness, dizziness, or sleeplessness occur • 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. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.