Active Ingredient (In Each 0.3 Ml)
Simethicone 20 mg
Mylicon Infants Gas Relief Dye Free Emulsion
FDA Label NDC 62372-650
9 label sections · Submitted to the FDA by Infirst Healthcare · 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 Dye Free (NDC 62372-650). 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, keep out of reach of children., directions, other information, inactive ingredients, questions or comments ?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Uses
relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.
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, 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
Mylicon® Infants' Drops
Simethicone-Antigas
Gas Relief
Gently breaks down baby’s gas bubbles
Dye Free Drops
Non-staining
Safe enough to use at every feeding and up to 12 times per day*
#1 Brand
Recommended by Pediatricians
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.
MYLICON ARTWORK 100 DOESE
Infants Mylicon Gas Relief 100 Doses (766df30mylfc)
* Please review the disclaimer below.
