FDA Label for Infants Gas Relief
View Indications, Usage & Precautions
Infants Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Supervalu 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
Use(S)
relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
Warnings
.
When Using This Product
do not exceed 12 doses per day
Keep Out Of The Reach Of Children
In case of overdose get medical help or contact a poison control center right away
Directions
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- fill enclosed dropper to recommended 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 under 2 | 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
Principal Display Panel
Compare to Mylicon® infant drops active ingredient*
NDC 41163-096-09
EQUALINE
infants'
gas relief
drops
simethicone 20 mg
(anti-gas)
- gently breaks down baby's gas bubbles
- safe enough to use at every feeding**
DYE-FREE
NON-STAINING
**USE AS DIRECTED
1 FL OZ (30 mL)
* Please review the disclaimer below.