Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Major Pharmaceuticals
ORAL
OTC DRUG
Expectorant helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
OTC monograph final
ROBAFEN- GUAIFENESIN SOLUTION MAJOR PHARMACEUTICALS _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._ ---------- MAJOR PHARMACEUTICALS ROBAFEN DRUG FACTS ACTIVE INGREDIENT (IN EACH 10 ML) Guaifenesin, USP 200 mg PURPOSE Expectorant USE helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive WARNINGS ASK A DOCTOR BEFORE USE IF YOU HAVE • • 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. A persistent cough may be a sign 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 (1- 800-222-1222). DIRECTIONS • • ™ cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema do not take more than 6 doses in any 24-hour period measure only with dosing cup provided • • • age dose adults and children 12 years and over 10 – 20 mL every 4 hours children under 12 years do not use OTHER INFORMATION • INACTIVE INGREDIENTS anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate QUESTIONS OR COMMENTS? 1-800-616-2471 PRINCIPAL DISPLAY PANEL ROBAFEN Congestion Formula Guaifenesin, USP 200 mg Expectorant Relieves: Mucus Chest Congestion Cherry Flavor Dosing Cup Included Alcohol Free For Adults Ages 12 and Over 4 FL OZ (118 mL) keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age store at 20-25 C (68-77 F). Do not refrigerate. ° ° ™ ROBAFEN guaifenesin solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOUR Baca dokumen lengkap