FDA Label for Mylicon Infants Gas Relief Dye Free
View Indications, Usage & Precautions
Mylicon Infants Gas Relief Dye Free Product Label
The following document was submitted to the FDA by the labeler of this product Infirst Healthcare. 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 (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, 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
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.
* Please review the disclaimer below.