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.
Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mgChlorpheniramine maleate 1 mgDextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg
Pain reliever/fever reducerAntihistamineCough suppressantNasal decongestant
- •temporarily relieves •minor aches and pains •headache •minor sore throat pain •runny nose •itchy nose or throat •sneezing •itchy, watery eyes due to hay fever •nasal and sinus congestion •cough due to minor throat and bronchial irritation as may occur with a cold •temporarily reduces fever
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes •more than 5 doses in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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
- •in a child under 4 years of age •if your child is allergic to acetaminophen •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. •in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. •for the purpose of making your child sleepy
Ask A Doctor Before Use If The Child Has
- •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •glaucoma •a breathing problem such as chronic bronchitis •cough that occurs with too much phlegm (mucus) •chronic cough that lasts, such as occurs with asthma
Ask A Doctor Or Pharmacist Before Use If The Child Is
- Taking •sedatives or tranquilizers •the blood thinning drug warfarin
When Using This Product
- •do not exceed recommended dosage •marked drowsiness may occur •sedatives and tranquilizers may increase drowsiness •excitability may occur, especially in children
Stop Use And Ask A Doctor If
- •nervousness, dizziness, or sleeplessness occur •pain, nasal congestion or cough gets worse or lasts more than 5 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.
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 even if you do not notice any signs or symptoms.
- •this product does not contain directions or complete warnings for adult use •do not give more than directed •shake well before use •may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor. •use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.Age Dosechildren under 4 years of agedo not usechildren 4 to under 6 years of agedo not use unless directed by a doctorchildren 6 to under 12 years of age10 mL
- •each 5 mL contains: sodium 3 mg •contains no aspirin •store at controlled room temperature 20-25°C (68-77°F). Protect from light. •close cap tightly
Anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum
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