FDA Label for Pediacare Simethicone Antigas
View Indications, Usage & Precautions
Pediacare Simethicone Antigas Product Label
The following document was submitted to the FDA by the labeler of this product Strides Pharma 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
(provided as simethicone emulsion 66.7 mg)
Purpose
Antigas
Uses
relieves the symptoms of 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 (1-800-222-1222) right away.
Directions
- shake well before using
- find right dose on chart below. If possible, use weight to determine dose; otherwise, use age.
- measure only with the enclosed syringe
- remove cap and insert syringe into the bottle. Fill syringe to recommended dosage level.
- dispense liquid slowly into child's mouth, toward inner cheek
- may be mixed with 1 oz. of cool water, infant formula or other suitable liquids
- 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
- clean syringe and replace cap tightly on bottle
- mL = millilitre
| Age(yrs) | weight(lbs) | dose |
| infants under 2 | under 24 | 0.3mL |
| children 2 and over | 24 and over | 0.6mL |
Other Information
- do not freeze
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavor, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate , sucralose, xanthan gum
Questions
1-888-474-3099
Monday – Friday 8 am to 5 pm
Eastern standard time.
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INFANTS 0-36 months
PediaCare®
Gas Relief DROPS
SIMETHICONE-ANTIGAS
DYE-FREE Berry Flavor
1 FL OZ (30 mL)
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