CHILDRENS COLD, COUGH AND SORE THROAT- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Drug Facts Active ingredients (in each 10 mL or 2 teaspoons) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCL 5 mg

Available from:

Chain Drug Consortium, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant - temporarily relieves these common cold and flu symptoms: - nasal congestion - minor aches and pains - headache - stuffy nose - sore throat - fever - cough due to minor throat and bronchial irritation - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes - with any other drugs 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. - liver disease - high blood pressure - diabetes - heart disease - thyroid disease - a breathing problem such as chronic bronc

Authorization status:

OTC monograph not final

Summary of Product characteristics

CHILDRENS COLD, COUGH AND SORE THROAT - ACETAMINOPHEN, GUAIFENESIN,
DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL LIQUID
CHAIN DRUG CONSORTIUM, LLC
_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
DRUG FACTS
ACTIVE INGREDIENTS
(IN EACH 10 ML OR 2 TEASPOONS)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg
PURPOS E
PURPOSE
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
center right away.
US ES
temporarily relieves these common cold and flu symptoms:
nasal congestion
minor aches and pains
headache
stuffy nose
sore throat
fever
cough due to minor throat and bronchial irritation
helps loosen phlegm (mucus) and thin bronchial secretions to drain
bronchial tubes
WARNINGS
LIVER WARNING: This product contains acetaminophen. Sever liver damage
may occur if your child if
your child takes
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
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
with any other drugs 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 two weeks after
stopping the MAOI drug. If you do not know if your child’s
prescription drug contains an MAOI,
ask a doctor or a pharmacist before taking this product.
ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
liver disease
high blood