FDA Label for Premier Value Infants Gas Relief
View Indications, Usage & Precautions
Premier Value Infants Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium. 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 discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
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. cool water, infant formula or other suitable liquids• clean dropper after each use - replace bottle with original cap
age (yr) | weight (lb) | dose |
infants under 2 | under 24 | 0.3 mL |
children over 2 | over 24 | 0.6 mL |
Other Information
• do not use if printed seal under cap is torn or missing• store at room temperature• do not freeze• see bottom panel for lot and expiration date
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol.
Principal Display Panel
Compare to active ingredient in Mylicon® Infants' Drops
Premier Value
Infants' Drops
Gas Relief
Simethicone 20 mg
Non-Staining formula
Dye Free/Alcohol Free
No artificial flavors
Safe enough to use at every feeding
1 Fl. OZ (30ml)
100 Doses
Distributed by
Chain Drug Consortium, LLC.
3301 N.W. Boca Raton Blvd.,
Suite 101, Boca Raton FL 33431
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