Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Denison Pharmaceuticals, Inc.
ORAL
OTC DRUG
Antigas Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food.
OTC monograph final
LITTLE REMEDIES GAS RELIEF DROPS- SIMTHICONE LIQUID DENISON 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._ ---------- LITTLE REMEDIES GAS RELIEF DROPS _DRUG FACTS_ ACTIVE INGREDIENT (IN EACH 0.3 ML) Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg PURPOS E Antigas US ES Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food. WARNINGS KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. DIRECTIONS shake well before using only use enclosed dropper / syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day dosage can also be mixed with 1 fl oz of cool water, infant formula or other suitable liquids for best results, clean dropper after each use and replace original cap If possible, use weight to determine dose; otherwise use age. ML = milliliter Age (yrs) Weight (lbs) Dose Newborns & Infants under 2 Under 24 0.3 mL Children 2 and over 24 and over 0.6 mL OTHER INFORMATION do not freeze store at room temperature 20°-25°C (68°-77°F) see bottle or box for lot number and expiration date INACTIVE INGREDIENTS carmellose sodium (and) microcrystalline cellulose, citric acid, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum QUES TIONS ? 1-800-754-8853 Mon. – Fri. 8:30 am to 5:30 pm EST LITTLEREMEDIES .COM PRINCIPAL DISPLAY PANEL Little Remedies Gas Relief Drops Simethicone / Antigas 0.5 FL OZ (15 mL) LITTLE REMEDIES GAS RELIEF DROPS simthicone liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 29 5-1237 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/AC Perskaitykite visą dokumentą