Best Choice Suspension/ Drops
FDA Label NDC 63941-709

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Best Choice (valu Merchandisers Company) for the product Best Choice (NDC 63941-709). 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 (in each 0.3 ml), purpose, uses, directions, other information, inactive ingredients, questions or comments?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Directions

  • ▪shake well before using
  • ▪find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • ▪Only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • ▪Remove cap and insert syringe into the bottle.
  • ▪Pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards 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 oz. cool water, infant formula or other suitable liquids.
  • ▪Replace cap tightly to maintain child resistance
  • ▪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 between 20-25°C (68-77°F)
  • ▪do not freeze
  • ▪see bottom panel for lot number and expiration date

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Best Choice®

COMPARE TO THE ACTIVE INGREDIENT IN INFANTS’ MYLICON® DROPS*

NDC 63941-709-01

INFANTS’

Gas Relief Drops

SIMETHICONE Anti-gas 20 mg

Dye-free

Non-staining formula

  • No alcohol
  • No saccharin
  • No artificial color
  • No artificial flavor

    • 1 FL OZ (30 mL) 100 DOSES

    Best Choice 100% Guaranteed

    www.bestchoicebrand.com

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

    *This product is not manufactured or distributed by McNeil Consumer Pharmaceuticals Co., the distributor of Infants’ MYLICON® Drops.

    Best Choice Infant Gas Relief Simethicone (766df30mylfc)

    Best Choice Infant Gas Relief Simethicone (766df30mylfc)

* Please review the disclaimer below.