1. Home
  2. Labeler Index
  3. Strategic Sourcing Services Llc
  4. 70677-1078
  5. Label Information: Foster And Thrive Infants Gas Relief

FDA Label for Foster And Thrive Infants Gas Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGRADIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Foster And Thrive Infants Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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(S)



Simethicone 20 mg


Purpose



Antigas


Use(S)



relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods


Warnings



.


When Using This Product



do not exceed 12 doses per day


Keep Out Of Reach Of Children.



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


Directions



  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids.
  • clean dropper after each use and close the bottle to maintain child resistance

    •  age (yr)weight (lb)dose
     infants under 2 under 240.3 mL
     children over 2  over 240.6 mL


Other Information



store at room temperature


Inactive Ingradients



benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum.


Questions Or Comments?



Call 833-358-6431 Monday to Friday 9:00 to 7:00 pm EST


Principal Display Panel



NDC 70677-1078-1

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS 

ACTIVE INGREDIENT* 

Foster and Thrive TM

INFANTS'

Gas Relief  Drops

Simethicone 20 mg

ANTIGAS

Relief of gas symptoms:

* Please review the disclaimer below.