Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Herbion Pakistan (Pvt.) Ltd
ORAL
OTC DRUG
Purposes Fever Reducer / Pain Reliever Cough suppressant Uses ■ temporarily relieves the following cold/flu symptoms: • minor aches and pains • headache •sore throat • cough ■ temporarily reduces fever 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 monograph final
CHILDRENS NOVEX COLD PLUS COUGH PLUS SORE THROAT- ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION HERBION PAKISTAN (PVT.) LTD _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- ACTIVE INGREDIENTS (IN EACH 5ML) Acetaminophen 160 mg Dextromethorphan HBr 5 mg PURPOS ES Fever Reducer / Pain Reliever Cough suppressant 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 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. 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 warfarin WHEN 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 lasts These could be signs of a serious condition 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 pharmacis read_full_document