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 ingredient (in each 5 mL)Acetaminophen 160 mg
Otc - Purpose
Purpose:fever reducer / Pain reliever
Indications & Usage
Uses:temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
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 diseaseAsk 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 gets worse or lasts more than 5 days■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness or swelling is presentThese 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.■ if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Otc - 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; tsp = teaspoonful■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.■ remove the child protective cap and use the dosing vial / measuring cup provided■ repeat dose every 4 hours while symptoms last■ do not give more than 5 times in 24 hoursWeight (lb) Age (yr) Dose (mL)*Under 24Under 2 years Ask a doctor24-352-3 years5 mL36-474-5 years7.5 mL48-596-8 years10 mL60-719-10 years12.5 mL72-9511 years15 mL*or as directed by a doctorAttention: use only enclosed dosing devices provided, specifically designed for use with this product.
Other Information■ each 5 mL (1 tsp) contains: sodium 1.2 mg■ store between 20-250C (68-770F)■ do not use if bottle cap seal is broken
Inactive Ingredients:Sucrose, Sorbitol, Glycerin, Flavor, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, FD&C RED NO. 40, Purified Water
Otc - Questions
Questions or Comments?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
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