País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Rugby Laboratories
ORAL
OTC DRUG
Cough suppressant temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
OTC monograph final
DEXTROMETHORPHAN HBR- DEXTROMETHORPHAN HBR CAPSULE, LIQUID FILLED RUGBY LABORATORIES _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._ ---------- RUGBY 44-732-DELISTED _ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)_ Dextromethorphan HBr, USP 15 mg _PURPOSE_ Cough suppressant _USE_ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold _WARNINGS_ DO NOT USE if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ASK A DOCTOR BEFORE USE IF YOU HAVE a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema STOP USE AND ASK A DOCTOR IF cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: take 2 capsules every 6 to 8 hours, as needed children under 12 years: do not use _OTHER INFORMATION_ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from light, heat and moisture see bottle for lot number and expiration date _INACTIVE INGREDIENTS_ FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol Leia o documento completo