Country: United States
Language: English
Source: NLM (National Library of Medicine)
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
RB Health (US) LLC
ORAL
OTC DRUG
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive - temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help your child get to sleep - nasal congestion due to a cold - stuffy nose
OTC monograph final
MUCINEX CHILDRENS COUGH AND CONGESTION- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE SUSPENSION RB HEALTH (US) 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._ ---------- MUCINEX® CHILDREN'S COUGH & CONGESTION _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH 5_ _ML)_ _PURPOSES_ Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant Phenylephrine HCl 2.5 mg Nasal decongestant USES helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose WARNINGS DO NOT USE 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. ASK A DOCTOR BEFORE USE IF THE CHILD HAS heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma WHEN USING THIS PRODUCT DO NOT USE MORE THAN DIRECTED STOP USE AND ASK A DOCTOR IF nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. DIRECTIONS do not give more than 6 doses in any 24-hou Read the complete document