Country: United States
Language: English
Source: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Ultra Seal Corporation
GUAIFENESIN
GUAIFENESIN 100 mg in 5 mL
ORAL
OTC DRUG
Purpose: Expectorant, Antitussive (Anti Cough) Uses: temporarily: • helps loosen phlegm (mucus) • thin bronchial secretions to drain bronchial tubes, and make coughs more productive. • restores free breathing • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
OTC monograph final
ULTRA TUSS DM- GUAIFENESIN DEXTROMETHORPHAN HBR SYRUP ULTRA SEAL CORPORATION _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._ ---------- DRUG FACTS ACTIVE INGREDIENTS (IN 5 ML) Guaifenesin 100 mg Dextromethorphann HBr 10 mg PURPOSE: Expectorant, Antitussive (Anti Cough) USES: temporarily: • helps loosen phlegm (mucus) • thin bronchial secretions to drain bronchial tubes, and make coughs more productive. • restores free breathing • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product. • more than the recommended dose. STOP USE AND ASK A DOCTOR IF: • symptoms do not improve within 7 days or are accompanied by fever. • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These can be signs of a serious condition. ASK A DOCTOR BEFORE USE IF YOU HAVE: • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) 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. Prompt medical attention is critical for adults as well as children even if ou do not notice any signs or symptoms. DIRECTIONS : Do not exceed 6 doses in any 24 hour period. Adults and children 12 years of age and older: Take 2 teaspoons (10 ml) every 4 hours as needed, or as directed by a doctor. Child Read the complete document