The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients (in each 30 mL dose cup)PurposeAcetaminophen 650 mgPain reliever/fever reducerDextromethorphan HBr 30 mgCough suppressantDoxylamine succinate 12.5 mgAntihistamine
- Temporarily relieves common cold/flu symptoms: •cough due to minor throat and bronchial irritation •sore throat •headache •minor aches and pains •fever •runny nose and sneezing
- This product contains acetaminophen. Severe liver damage may occur if you take▪more than 4 doses in 24 hours, which is the maximum daily amount for this product▪with other drugs containing acetaminophen▪3 or more alcoholic drinks every day while using this product
Sore Throat Warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.▪to make a child sleep
Ask A Doctor Before Use If You Have
- ▪liver disease▪glaucoma▪cough that occurs with too much phlegm (mucus)▪a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema▪trouble urinating due to enlarged prostate gland▪a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
- ▪taking sedatives or tranquilizers▪taking the blood thinning drug warfarin
When Using This Product
- ▪excitability may occur, especially in children▪marked drowsiness may occur▪avoid alcoholic drinks▪be careful when driving a motor vehicle or operating machinery▪alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- ▪pain 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 rash or headache that lasts.These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Taking more than the recommended dose 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 do not notice any signs or symptoms.
- •take only as directed •only use the dose cup provided •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use
- •each 30 mL contains: sodium 16 mg •store at room temperature and do not refrigerate
Anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose, xanthan gum
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