NDC 0363-0790 Walgreens Infants Dye Free Gas Relief

Simethicone

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  2. Walgreen Co.
  3. NDC: 0363-0790 Walgreens Infants Dye Free Gas Relief

NDC Product Code 0363-0790

NDC CODE: 0363-0790

Proprietary Name: Walgreens Infants Dye Free Gas Relief 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.
Non-Proprietary Name: Simethicone 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

Product Characteristics

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

NDC Code Structure

  • 0363 - Walgreen Co.
    • 0363-0790 - Walgreens Infants Dye Free Gas Relief

NDC 0363-0790-30

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

NDC Product Information

Walgreens Infants Dye Free Gas Relief with NDC 0363-0790 is a 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 RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 198857.

Dosage Form: Emulsion - 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.)

Product Type: Human Otc Drug 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.

Walgreens Infants Dye Free Gas Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • SORBITOL (UNII: 506T60A25R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

Labeler Name: Walgreen Co.
Labeler Code: 0363
FDA Application Number: part332 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.
Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.
Start Marketing Date: 08-30-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 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.
Exclude Flag: N - NO 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".

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Information for Patients

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 Images

Walgreens Infants Dye Free Gas Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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= milliliterAge (yr)Weight (lb)Dose( mL)infants under 2under 240.3 children over 2over 240.6

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

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