CHILDRENS NOVEX COLD PLUS COUGH PLUS SORE THROAT- acetaminophen and dextromethorphan hydrobromide suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

Herbion Pakistan (Pvt.) Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
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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