FDA Label for Gas Relief
View Indications, Usage & Precautions
Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. 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
- may be mixed with 1 oz of water, infant formula or other suitable liquid
- for best results, clean dropper after each use and replace original cap
Age (years) | Weight (lbs) | Dose |
infants (under 2)
| under 24
| 0.3 mL
|
children (over 2)
| over 24
| 0.6 mL
|
Other Information
- store at room temperature
- do not freeze
- see bottom panel for lot number and expiration date
- TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.
Questions Or Comments?
1-800-645-2158
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
Package Label
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