Mylicon Infants Gas Relief Original Emulsion
FDA Label NDC 62372-630

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Infirst Healthcare for the product Mylicon Infants Gas Relief Original (NDC 62372-630). 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. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your 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 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, D&C Red 22, D&C Red 28, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions Or Comments?

Call 1-855-848-3284 toll free (English and Spanish)

Principal Display Panel

Infants' Mylicon®

Simethicone-Antigas

Gas Relief

Gently breaks down baby’s gas bubbles

Original Drops

Non-staining

Safe enough to use at every feeding and up to 12 times per day*

#1 Brand

Recommended by Pediatricians

1 Fl. OZ (30ml)

100 Doses

Visit us at mylicon.com

No Alcohol

No Artificial Flavors

No Saccharin

Gluten Free

Safe enough to use at every feeding and up to 12 times per day*

Safe enough for even the newest of newborns*

*use as directed

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Important: Keep this carton for future reference on full labeling

Manufactured for

infirst Healthcare Inc.

Westport, CT 06880

©2015 infirst Healthcare Inc.

Infants Mylicon Gas Relief Original (766df30mylfc)

Infants Mylicon Gas Relief Original (766df30mylfc)

* Please review the disclaimer below.