FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 12 tablets in 24 hours, which is the maximum daily amount for this product
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks everyday while using this product
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). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist.
■ for 2 weeks after stopping the MAOI drug
Ask a doctor before use if you have
■ liver disease ■ heart disease ■ high blood pressure ■ diabetes
■ thyroid disease ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive 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 exceed recommended dosage
■ may cause excitability especially in children
■ do not drive or operate machinery
■ avoid alcoholic beverages
■ may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Stop use and ask a doctor if
■ pain, cough, or nasal congestion gets worse or lasts more than 7 days
■ sore throat persists for more than 2 days
■ nervousness, dizziness, or sleeplessness occur
■ any of the following occurs (these could be signs of a serious condition):
■ fever gets worse or or lasts more than 3 days
■ a severe sore throat
■ sore throat is accompanied or followed by high fever, headache, rash, nausea or vomiting
■ redness or swelling is present
■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts
Do not give to children under 12 years of age unless directed by a doctor.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist.
■ for 2 weeks after stopping the MAOI drug
Ask a doctor before use if you have
■ liver disease ■ heart disease ■ high blood pressure ■ diabetes
■ thyroid disease ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
Stop use and ask a doctor if
■ pain, cough, or nasal congestion gets worse or lasts more than 7 days
■ sore throat persists for more than 2 days
■ nervousness, dizziness, or sleeplessness occur
■ any of the following occurs (these could be signs of a serious condition):
■ fever gets worse or or lasts more than 3 days
■ a severe sore throat
■ sore throat is accompanied or followed by high fever, headache, rash, nausea or vomiting
■ redness or swelling is present
■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion
■ runny nose ■ sinus congestion and pressure
■ cough due to minor throat and bronchial irritation
■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
■ temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Stona Manufacturers
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Sato Pharmaceutical Co., Ltd.
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