FDA Label for Mommys Bliss Gas Relief Simethicone Drops

View Indications, Usage & Precautions

Mommys Bliss Gas Relief Simethicone Drops Product Label

The following document was submitted to the FDA by the labeler of this product Mom Enterprises, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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:




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