Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
NuCare Pharmaceuticals,Inc.
ORAL
OTC DRUG
Antigas relieves the symptoms referred to as gas
OTC monograph final
SIMETHICONE- SIMETHICONE SUSPENSION/ DROPS NUCARE 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._ ---------- RUGBY INFANT DROPS ACTIVE INGREDIENT (IN EACH 0.3 ML) Simethicone 20 mg PURPOS E Antigas US E relieves the symptoms referred to as gas WARNINGS KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a poison control center right away. DIRECTIONS shake well before using 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 fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek may be mixed with 1 oz of water, infant formula or other suitable liquid for best results, clean dropper after each use and replace original cap AGE (YEARS) WEIGHT (LBS) DOS E infants (under 2) under 24 0.3 mL children (over 2) over 24 0.6 mL OTHER INFORMATION store at room temperature do not freeze see bottom panel for lot number and expiration date TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING INACTIVE INGREDIENTS carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum. QUESTIONS OR COMMENTS? 1-800-645-2158 PACKAGE LABEL SIMETHICONE simethicone suspension/ drops PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 8 0 71-420 7(NDC:0 536 -2220 ) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O) DIMETHICONE 20 mg in 0 .3 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311) ANHYDRO US CITRIC ACID (UNII: XF417D3PSL) MALTITO L (UNII: D6 5DG142WK) CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 Lire le document complet