Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI
Drug Details
- Generic Name
- Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI
- Brand Names
- SanaTos Multi Symptom
- Application Number
- M012
- Sponsor
- Pharmadel LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Indications and Usage
Uses KICKSTART SEVERE COLD & FLU: 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 NIGHT TIME SEVERE COLD & FLU: temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■ minor aches and pains ■ sore throat ■ headache ■ sinus congestion and pressure ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep
Warnings
Warnings KICKSTART SEVERE COLD & FLU: 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. 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 ■ heart disease ■ diabetes ■ high blood pressure ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus) 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 ■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion, or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. NIGHT TIME SEVERE COLD & FLU: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4,000 mg 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. 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 ■ heart disease ■ diabetes ■ high blood pressure ■ thyroid disease ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion, or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back, or occurs with fever, rash, or headache that lasts . These could be signs of a serious condition.