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 - Active Ingredient
Active ingredients(in each 5mL)Acetaminophen 160 mg Dextromethorphan HBr 5 mg
Otc - Purpose
PurposesFever Reducer / Pain RelieverCough suppressant
Indications & Usage
Uses■ temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache •sore throat • cough■ 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.
Otc - Ask Doctor
Ask a doctor before use if your child has■ liver disease ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarinWhen using this product do not exceed recommended dose (see overdose warning)Stop use and ask a doctor if■ pain or cough gets worse or lasts more than 5 days■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness or swelling is present■ cough comes back with rash or headache that lastsThese could be signs of a serious condition
Otc - Do Not Use
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.■ 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.■ if your child has ever had an allergic reaction to this product or any of its ingredients
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (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.
Dosage & Administration
Directions■ this product does not contain directions or complete warnings for adult use■ do not give more than directed (see overdose warning)■ shake well before using■ mL = milliliter■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.■ remove the child protective cap and squeeze your child's dose into the dosing cup■ repeat dose every 4 hours, while symptoms last■ do not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (mL)*Under 36Under 4 yearsDo not use36-474-5 years5 mL48-956-11 years10 mL*or as directed by a dosctorAttention: use only enclosed dosing cup provided, specifically designed for use with this product.
Other Safety Information
Other Information:■ store between 68-770F (20-250C)■ do not use if bottle cap seal is broken
Inactive Ingredients:Carboxymethylcellulose sodium, FD&C Red No. 40, Flavor, Glycerin, Potassium Sorbate, Purified water, Sodium benzoate, Sorbitol solution, Sucrose, Sucralose, Xanthan gum
Otc - Questions
Questions or Comments?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
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