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| Product NDC Code | 36800-119 | ||||
|---|---|---|---|---|---|
| Drug Name | Infants gas relief |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| Application Number | part332 | ||||
| Labeler Name | Topco Associates, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT (in each 0.3 mL) Simethicone 20 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS shake well before using all dosages may be repeated as needed, after meals and at bedtime fill enclosed dropper to recommended dosage level dispense liquid slowly into baby's mouth, toward the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids clean dropper after each use and close the bottle to maintain child resistance age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL
| age (yr) | weight (lb) | dose |
| infants under 2 | under 24 | 0.3 mL |
| children over 2 | over 24 | 0.6 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS SECTION benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE(S) relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
Purpose
Information about the drug product’s indications for use.PURPOSE Antigas
Spl product data elements
Usually a list of ingredients in a drug product.Infants Gas relief Simethicone DIMETHICONE DIMETHICONE BENZOIC ACID MAGNESIUM ALUMINUM SILICATE WATER SORBITOL XANTHAN GUM off-white
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Topcare health COMPARE TO MYLICON ® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT* NDC 36800-119-09 NON-STAINING DYE-FREE infants' Gas Relief Drops SIMETHICONE 20 mg ANTI-GAS Gently Breaks Down Baby's Gas Bubbles Safe Enough to Use at Every Feeding** **use as directed 1 FL OZ (30 mL) 74
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION store at room temperature
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS When using this product do not exceed 12 doses per day
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API