Country: United States
Language: English
Source: NLM (National Library of Medicine)
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS), Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)
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 - 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
OTC monograph final
MUCINEX CHILDRENS COUGH- DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SOLUTION 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 _DRUG FACTS_ _ACTIVE INGREDIENTS (IN EACH 5_ _ML)_ _PURPOSES_ Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant 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 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 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 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-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor AGE DOSE children 6 years to under 12 years of age 5 mL – 10 mL every 4 hours children 4 years to under 6 years of age 2.5 mL – 5 mL every 4 hours children under 4 years of age d Read the complete document