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 Pain reliever/fever reducer
Indications & Usage
Uses temporarily:■ reduces fever■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
WarningsLiver warning: This product contains acetaminophen. Severeliver damage may occur if your child takes■ more than 5 doses in 24 hours, which is the maximum dailyamount■ with other drugs containing acetaminophenAllergy alert: Acetaminophen may cause severe skinreactions. Symptoms may include:■ skin reddening ■ blisters ■ rash.If a skin reaction occurs, stop use and seek medical help rightaway.Sore throat warning: if sore throat is severe, persists for morethan 2 days, is accompanied or followed by fever, headache,rash, nausea, or vomiting, consult a doctor promptly.
Otc - Do Not Use
Do not use■ with any other drug containing acetaminophen (prescriptionor nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist■ if your child is allergic to acetaminophen or any of theinactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is takingthe blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose(see overdose warning)
Otc - Stop Use
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.
Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warningIn case of overdose, get medical help or contact a PoisonControl Center right away. (1-800-222-1222) Quick medicalattention is critical for adults as well as for children even if youdo not notice any signs or symptoms.
Dosage & Administration
Directions■ this product does not contain directions or complete warnings for adult use.■ shake well before using■ mL = milliliter■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.■ if needed, repeat dose every 4 hours while symptoms last.■ do not give more than 5 times in 24 hours.■ do not give for more than 5 days unless directed by a doctor.Dosing Chart Weight (lb)Age (yr) Dose (mL)*Under 24 Under 2 years Ask a doctor 24 -35 2 -3 years 5 mL*or as directed byAttention: use only enclosed dosingsyringe specifically designed for usewith this product. Do not use any otherdosing device.
Other Safety Information
Other information■ each 5 ml contains: sodium 3 mg■ store between 20-25°C (68-77oF)■ do not refrigerate
Inactive ingredientsanhydrous citric acid, butylparaben,FD&C red #40, flavor, glycerin, highfructose corn syrup, microcrystallinecellulose and carboxymethylcellulosesodium, propylene glycol, purified water,sodium benzoate, sorbitol solution,sucralose, xanthan gum
Otc - Questions
Questions? Call weekdays from 9:30AM to 4:30 PM EST at 1-877-798-5944
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