Foster And Thrive Infants Gas Relief Solution/ Drops
FDA Label NDC 70677-1078

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Infants Gas Relief (NDC 70677-1078). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

  • Pressure
  • Bloating
    • Non-staining Formula
    • Alcohol Free
    • Saccharin Free

      • 1 FL. OZ. (30 mL) 100 Doses

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* Please review the disclaimer below.