FDA Label for Infants Gas Relief Drops
View Indications, Usage & Precautions
Infants Gas Relief Drops Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores,inc.,. 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.• 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.• fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.• dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids• clean dropper well after each use-recap bottle with original cap• 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, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.
Questions?
1-866-467-2748
Principal Display Panel
Compare to active ingredient in infant’s Mylicon Drops*
Infants'
Gas Relief
Drops
Simethicone 20 mg /Antigas
• No Saccharin• No Artificial Colors• No Artificial Flavor
1 FL. OZ. (30 mL) 100 doses
Distributed by:
* This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops.
* Please review the disclaimer below.
