Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel COMPARE TO CHILDREN'S TYLENOL® PLUS COUGH & RUNNY NOSE ACTIVE INGREDIENTS* Children's Pain Relief Plus Cough & Runny Nose ORAL SUSPENSION ACETAMINOPHEN 160 mg PAIN RELIEVER • REVER REDUCER CHLORPHENIRAMINE MALEATE 1 mg ANTIHISTAMINE DEXTROMETHORPHAN HBr 5 mg COUGH SUPPRESSANT RELIEVES: Fever Sore Throat Sneezing Runny Nose Cough Ages 6 to 11 Years CHERRY FLAVOR Alcohol 0.005% FL OZ (mL) *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Cough & Runny Nose. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 [email protected] www.topcarebrand.com; Package Label TOPCARE HEALTH Children's Pain Relief Plus Cough & Runny Nose Acetaminophen 160mg Chlorpheniramine Maleate 1 mg, Dextromethorphan HBr 5 mg
- Principal Display Panel COMPARE TO CHILDREN'S TYLENOL® PLUS COUGH & RUNNY NOSE ACTIVE INGREDIENTS* Children's Pain Relief Plus Cough & Runny Nose ORAL SUSPENSION ACETAMINOPHEN 160 mg PAIN RELIEVER • REVER REDUCER CHLORPHENIRAMINE MALEATE 1 mg ANTIHISTAMINE DEXTROMETHORPHAN HBr 5 mg COUGH SUPPRESSANT RELIEVES: Fever Sore Throat Sneezing Runny Nose Cough Ages 6 to 11 Years CHERRY FLAVOR Alcohol 0.005% FL OZ (mL) *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Cough & Runny Nose. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 [email protected] www.topcarebrand.com
- Package Label TOPCARE HEALTH Children's Pain Relief Plus Cough & Runny Nose Acetaminophen 160mg Chlorpheniramine Maleate 1 mg, Dextromethorphan HBr 5 mg
Overview
Uses temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache temporarily reduces fever
Indications & Usage
Uses temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache temporarily reduces fever
Dosage & Administration
Directions this product does not contain directions or complete warnings for adult use. mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use age Weight (lb) Age (yr) Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use
Warnings & Precautions
Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount with other drugs contaning acetaminophen Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If 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 to make a child sleepy 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. with any other drug containing acetaminophen (prescription or non-prescription). 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. Ask a doctor before use if the child has liver disease glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough 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 dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adult as well as children even if you do not notice any signs or symptoms.
Purpose
Purposes Pain reliever/fever reducer Antihistamine Cough suppressant
Do Not Use
Do not use to make a child sleepy 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. with any other drug containing acetaminophen (prescription or non-prescription). 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.
When Using
When using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness
Stop Use & Ask a Doctor
Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days 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
Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adult as well as children even if you do not notice any signs or symptoms.
Questions
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