Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
MOM Enterprises, Inc
ORAL
OTC DRUG
Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
OTC monograph final
MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS- DIMETHICONE SOLUTION/ DROPS MOM ENTERPRISES, 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._ ---------- MOMMY'S BLISS GAS RELIEF SIMETHICONE DROPS _DRUG FACTS_ ACTIVE INGREDIENT (IN EACH 0.3 ML) Simethicone 20 mg _PURPOSE_ Antigas _USES_ Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods _WARNINGS_ KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms. _DIRECTIONS_ SHAKE WELL BEFORE USING find right dose on chart below. If possible, use weight to dose; otherwise, use age. 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 the inner cheek dosage can also be mixed with 1 oz, cool water, infant formula or other suitable liquids clean dropper well after each use mL = milliliter Age (yr) Weight (lb) Dose (mL) infants under 2 under 24 0.3 children over 2 over 24 0.6 _OTHER INFORMATION_ TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING store at room temperature do not freeze see bottom panel for lot number and expiration date _INACTIVE INGREDINETS_ carboxymethylcellulose sodium, citric acid, ginger extract, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, stevia extract, xanthan gum. _QUESTIONS?_ Call 1-877-457-4955 PACKAGE LABELING: MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS dimethicone solution/ drops PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:71444-789 ROUTE OF ADMINISTRATION O Baca dokumen lengkapnya