NDC 59779-701 Infants Gas Relief Original Formula

Product Information

What is NDC 59779-701?

The NDC code 59779-701 is assigned by the FDA to the product Infants Gas Relief Original Formula which is product labeled by Cvs. The product's dosage form is . The product is distributed in a single package with assigned NDC code 59779-701-01 36 carton in 1 box / 1 bottle, dropper in 1 carton / 30 ml in 1 bottle, dropper. 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 Code59779-701
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 Original Formula
NDC Directory StatusINACTIVATED PRODUCT and excluded from NDC Directory
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Cvs
Labeler Code59779
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.
01-05-2013
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

What are the uses for Infants Gas Relief Original Formula?


Product Characteristics

Color(s)PINK (C48328 - OPAQUE)
Flavor(s)VANILLA (C73421)
STRAWBERRY (C73417)

Product Packages

NDC Code 59779-701-01

Package Description: 36 CARTON in 1 BOX / 1 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 Original Formula 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:

Infants Gas Relief Original Formula 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.

* Please review the disclaimer below.

Infants Gas Relief Original Formula 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



Other



Drug Facts

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895


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
  • fill enclosed dropper to recommended dosage level 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 dropper 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 printed foil seal under cap 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, Red #3, Sodium Benzoate, Sodium Citrate, Sucralose


Principal Display Panel - 30 Ml Bottle Carton



CVS
pharmacy
®

Compare to the
active ingredient in
Infants' MYLICON® Drops*

Infants'
GAS
RELIEF
ORIGINAL FORMULA

SIMETHICONE/ANTIGAS

* Please review the disclaimer below.