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 Atlantic Biologicals Corps. 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
relieves the symptoms referred to as gas
Warnings
Otc - Keep Out Of Reach Of Children
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 inner cheek
- dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper well after each use and replace original cap
| 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 foil seal under cap is broken or missing.
- store at room temperature
- do not freeze
- see bottom panel for lot number and expiration date
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, maltitol, microcrystalline cellulose, flavor, purified water, sodium benzoate, sodium citrate, xanthan gum
Questions Or Comments?
(800)616-2471
How Supplied
Product: 17856-5894
NDC: 17856-5894-1 10 mL in a CUP
NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE
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