NDC 0363-0790 Walgreens Infants Dye Free Gas Relief
Simethicone Emulsion Oral

Product Information

What is NDC 0363-0790?

The NDC code 0363-0790 is assigned by the FDA to the product Walgreens Infants Dye Free Gas Relief which is a human over the counter drug product labeled by Walgreen Co.. The generic name of Walgreens Infants Dye Free Gas Relief is simethicone. The product's dosage form is emulsion and is administered via oral form. The product is distributed in a single package with assigned NDC code 0363-0790-30 1 bottle in 1 carton / 30 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0363-0790
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Walgreens Infants Dye Free Gas Relief
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Simethicone
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormEmulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Walgreen Co.
Labeler Code0363
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part332
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-30-2017
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Walgreens Infants Dye Free Gas Relief?


Product Characteristics

Color(s)WHITE (C48325 - WHITE TO OFF WHITE, OPAQUE)

Product Packages

NDC Code 0363-0790-30

Package Description: 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

Product Details

What are Walgreens Infants Dye Free Gas Relief Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Walgreens Infants Dye Free Gas Relief Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Walgreens Infants Dye Free Gas Relief Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Simethicone

Simethicone is pronounced as (sye meth' i kone)

Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]

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Walgreens Infants Dye Free Gas Relief Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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
  • •find right dose on chart below. if possible, use weight to dose; otherwise use age.
  • • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • • remove cap and insert syringe into the bottle.
  • • pull syringe up until filled to the prescribed level, if you pass the prescribed level, simply push syringe back until you have reached the desired level, Slowly dispense the liquid into your child’s mouth (towards inner cheek)
  • •all dosages may be repeated needed, after meals and at bedtime or as directed by a physician.
  • •do not exceed 12 doses per day.
  • •dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • •replace cap tightly to maintain child resistance
  • •mL= milliliter
  • Age (yr)

    Weight (lb)

    Dose( mL)

    infants under 2

    under 24

    0.3

    children over 2

    over 24

    0.6


Other Information



  • tamper evident:do not use if printed 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, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.


Questions?



1-866-467-2748


Principal Display Panel



Walgreens

Compare to infant’s Mylicon Gas Relief active ingredient††

Infants'

Dye- Free

Gas Relief

Simethicone 20 mg PER DOSE /ANTI-GAS

  •  DYE FREE
  •  NONSTAINING FORMULA
  •  ALCOHOL FREE
    • •No saccharin
    • •No artificial flavor
    • •Includes dosing syringe
    • 100 DOSES DYE FREE

      1 FL OZ (30 mL)

      200 WILMOT RD., DEERFIELD, IL 60015

      100% SATISFACTION GUARANTEED

      Walgreens.com ©2017 Walgreen Co,

      WALGREENS PHARMACIST RECOMMENDED‡

      ‡Walgreens Pharmacist Survey

      ‡‡ This product is not manufactured or distributed by infirst Healthcare Inc., the distributor of Infants’ Mylicon® Gas Relief.

      IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
       

* Please review the disclaimer below.