FDA Label for Simethicone Infant Gas Relief Drops
View Indications, Usage & Precautions
Simethicone Infant Gas Relief Drops Product Label
The following document was submitted to the FDA by the labeler of this product Aarna Usa 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
Uses
relieves the symptoms referred to as gas
Directions
- shake well before using
- all dosages may be repeated as needed, alter 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
Age (years) | Weight (lbs) | Dose |
infants (under 2) | under 24 | 0.3 mL |
children (2 and over) | 24 and over | 0.6 mL |
Other Information
- TAMPER-EVIDENT: Do not use if printed seal under cap is broken or punctured
- store at room temperature
- do not freeze
- see bottom panel for lot number and expiration date
Inactive Ingredients
Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.
Questions Or Comments ?
Call toll-free 1-877-225-6999.
Manufactured for:
AARNA USA Inc.
Leland, NC-28451
Package Label.Principal Display Panel
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