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 Winco Foods, Llc. 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 symptoms of gas frequently caused by air swallowing or certain formulas or foods
Otc - Keep Out Of Reach Of Children
Warnings
When Using This Product
do not exceed 12 doses per day
Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.
Directions
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- fill enclosed dropper to recommend dosage level
- dispense liquid slowly into baby's mouth, toward the inner cheek
- may mix with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper after each use and close the bottle to maintain child resistance
| age (yr) | weight (lb) | dose |
| infants under2 | under 24 | 0.3 mL |
| children over 2 | over 24 | 0.6 mL |
Other Information
store at room temperature
Inactive Ingredients
benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum
Questions?
1-800-824-1706 Monday - Friday 9am-4pm MST.
You may also report side effects to this phone number
Principal Display Panel
*Compare to the active ingredient in MYLICON® Non-Staining Infants Drops
Infants Gas Relief Drops
Simethicone 20 mg / Anti-Gas
Soothing Relief for: Pressure, Bloating & Gas Symptoms
Alcohol Free
Dye Free
1 fl oz (30 mL)
* Please review the disclaimer below.