Country: United States
Language: English
Source: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
RB Health (US) LLC
ORAL
OTC DRUG
- temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose sneezing cough - minor aches and pains - headache - sore throat - nasal congestion - runny nose - sneezing - cough - controls cough to help your child get to sleep - temporarily reduces fever
OTC monograph final
MUCINEX CHILDRENS NIGHT TIME MULTI-SYMPTOM COLD- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE 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 NIGHT TIME MULTI-SYMPTOM COLD _DRUG FACTS_ _ACTIVE INGREDIENTS_ _(IN EACH 10 ML)_ _PURPOSES_ ACETAMINOPHEN 325 MG PAIN RELIEVER/FEVER REDUCER Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant USES temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose sneezing cough controls cough to help your child get to sleep temporarily reduces fever WARNINGS 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. 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. to make a child sleepy with any other product containing diphenhydramine, even one used on the skin 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 Read the complete document