FDA Label for Gas Relief Drops Infants
View Indications, Usage & Precautions
Gas Relief Drops Infants Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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
Principal Display Panel
compare to Mylicon Infants Drops active ingredient
gas relief drops infant's
Fast relief of gas symptoms
Alcohol and saccharin Free
non-staining
1 fl oz (30 mL) 100 Doses
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