Label: MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS- dimethicone solution/ drops
- NDC Code(s): 71444-789-01
- Packager: MOM Enterprises, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 16, 2019
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- Drug Facts
- Active ingredient (in each 0.3 mL)
- 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
- Inactive ingredinets
- Package Labeling:
INGREDIENTS AND APPEARANCE
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 ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 0.3 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GINGER (UNII: C5529G5JPQ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71444-789-01 1 in 1 BOX 01/05/2020 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 01/05/2020 Labeler - MOM Enterprises, Inc (135903776)