MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS- dimethicone solution/ drops

Mommys Bliss Gas Relief Simethicone Drops by

Drug Labeling and Warnings

Mommys Bliss Gas Relief Simethicone Drops by is a Otc medication manufactured, distributed, or labeled by MOM Enterprises, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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)