FDA Label for Infants
View Indications, Usage & Precautions
Infants Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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, 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 at room temperature▪ do not freeze▪ see bottom panel for lot number and expiration date
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum
Questions Or Comments?
1-800-645-2158
Principal Display Panel
Rugby®
Compare to the active ingredient in Infants’ Mylicon® Drops*
NDC 0536-1303-75
Infants’
Simethicone Drops
Antigas
• Dye-free• Non-staining formula• No Saccharin• No Artificial Color• No Artificial Flavor
1 FL OZ (30 mL) 100 DOSES
Distributed by:
RUGBY LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Syringe Enclosed. This bottle contains 100 doses (0.3 mL/dose)
*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON® Drops.
* Please review the disclaimer below.