País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)
Preferred Pharmaceuticals, Inc
Guaifenesin
Guaifenesin 100 mg in 5 mL
ORAL
OTC DRUG
Purpose: Expectorant Uses Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
OTC monograph final
SILTUSSIN SA- GUAIFENESIN LIQUID PREFERRED PHARMACEUTICALS, INC _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._ ---------- SILTUSSIN SA (GUAIFENESIN LIQUID) Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP)) Purpose: Expectorant USES 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 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 • • adults and children 12 years and over 2-4 teaspoonfuls (TSP) CHILDREN UNDER 12 YEARS DO NOT USE OTHER INFORMATION Store at room temperature 20°-25°C (68°-77°F). DO NOT ACCEPT IF IMPRINTED TAMPER EVIDENT SAFETY SEAL AROUND CAP IS BROKEN OR MISSING. INACTIVE INGREDIENTS citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, 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 repeat dose every 4 hours glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water. QUESTIONS 1-844-834-0530 Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave., Carmel, NY 10512 RELABELED BY: PREFERRED PHARMACEUTICALS INC. SILTUSSIN SA guaifenesin liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:68788-9098(NDC:54838-117) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH GUAIFENESIN (UNII: 495W7451VQ) (Guaif Leer el documento completo