NDC 0363-5773 Infants Gas Relief Non-staining Formula

  1. Labeler Index
  2. Walgreens
  3. NDC Product Code: 0363-5773 Infants Gas Relief Non-staining Formula

Product Information

Product Code0363-5773
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.		Infants Gas Relief Non-staining Formula
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Walgreens
Labeler Code0363
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.		06-15-2013
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.		12-31-2017
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". 		I
NDC Code Structure

Usage Information


Product Characteristics

Flavor(s)VANILLA (C73421)
STRAWBERRY (C73417)

Product Packages

NDC 0363-5773-01

Package Description: 2 BOTTLE, DROPPER in 1 CARTON > 30 mL in 1 BOTTLE, DROPPER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Infants Gas Relief Non-staining Formula is product labeled by Walgreens. The product's dosage form is and is administered via form.


What are Infants Gas Relief Non-staining Formula Active Ingredients?

The following is the list of active ingredients in this product. 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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE (UNII: 92RU3N3Y1O) (Active Moiety)


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • VANILLIN (UNII: CHI530446X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)


* Please review the disclaimer below.

Infants Gas Relief Non-staining Formula Labeling and Warnings

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.

Table of Contents



Other



Drug Facts

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015


Active Ingredient (In Each 0.3 Ml)



Simethicone 20 mg


Purpose



Anti-gas


Uses



Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.


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. (1-800-222-1222)


Directions



  • shake well before using
  • all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day
  • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle and dispense liquid slowly into baby's mouth, toward the inner cheek.
  • dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • for best results, clean syringe after each use and replace original cap
    • Age (yr)Weight (lb)Dose
    infants under 2under 240.3 mL
    children over 2over 240.6 mL

Other Information



  • Do not use if preprinted seal around the bottle is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive Ingredients



Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose


Questions Or Comments?



1-800-Walgreens (1-800-925-4733)


Principal Display Panel - 2-Bottle Carton



TWIN PACK X 1 FL OZ = 2 FL OZ

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

Infants'

Gas Relief

Simethicone 20 mg/Dose
Anti-Gas

• Nonstaining formula • No alcohol

• No saccharin • No artificial flavor

• New dosing syringe design

200 DOSES

Compare to Infants' Mylicon®
Drops active ingredient‡‡

2-1 FL OZ (30 mL) BOTTLES  TOTAL 2 FL OZ (60 mL)

Principal Display Panel - 2-Bottle Carton - gas relief 01

Principal Display Panel - 2-Bottle Carton - gas relief 01


* Please review the disclaimer below.