FDA Label for Little Remedies Gas Relief Drops

View Indications, Usage & Precautions

Little Remedies Gas Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products 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 Emulsion USP 66.7 mg/ Simethicone 20 mg


Purpose



Antigas


Uses



Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



  • shake well before using
  • only use enclosed dropper / syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek
  • 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
  • dosage can also be mixed with 1 fl oz of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
  • If possible, use weight to determine dose; otherwise use age.

    mL = milliliter

    Age (yrs)Weight (lbs)Dose
    Newborns & Infants under 2Under 240.3 mL
    Children 2 and over24 and over0.6 mL


Other Information



  • do not freeze
  • store at room temperature 20°-25°C (68°-77°F)
  • see bottle or box for lot number and expiration date

Inactive Ingredients



carmellose sodium (and) microcrystalline cellulose, citric acid, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum


Questions?



1-800-754-8853

Mon. – Fri. 8:30 am to 5:30 pm EST

LittleRemedies.com


Principal Display Panel



Little Remedies
Gas Relief Drops
Simethicone / Antigas
0.5 FL OZ (15 mL)

Little Remedies
Gas Relief Drops
Simethicone / Antigas
1.0 FL OZ (30 mL)


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