NDC 59779-701 Infants Gas Relief Original Formula

NDC Product Code 59779-701

NDC CODE: 59779-701

Proprietary Name: Infants Gas Relief Original Formula 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: 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.

Product Characteristics

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

NDC Code Structure

NDC 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.

NDC Product Information

Infants Gas Relief Original Formula with NDC 59779-701 is a product labeled by Cvs. The generic name of Infants Gas Relief Original Formula is . The product's dosage form is and is administered via form.

Labeler Name: Cvs

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.

  • 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)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cvs
Labeler Code: 59779
Start Marketing Date: 01-05-2013 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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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Infants Gas Relief Original Formula Product Label Images

Infants Gas Relief Original Formula 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

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 usingall doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per dayfill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheekdosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquidsfor best results, clean dropper after each use and replace original capAge (yr)Weight (lb)Doseinfants under 2under 240.3 mLchildren over 2over 240.6 mL

Other Information

  • Do not use if printed foil seal under cap is torn or missingstore at room temperaturedo not freezesee 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

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