FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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
Anti-gas
Uses
Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.
Keep Out Of 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 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
- dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
- for best results, clean dropper after each use and replace original cap
Age | Weight | Dose |
newborn | - - - - | 0.3 mL |
infants under 2 years | under 24 lbs | 0.3 mL |
children over 2 years | over 24 lbs | 0.6 mL |
Other Information
- store at room temperature 15°- 30°C (59°- 86°F)
- do not freeze
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredients
carbomer, citric acid, FD&C red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate
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