NDC 30142-171 Infants Gas Relief Dye Free

Simethicone Antigas

NDC Product Code 30142-171

NDC Code: 30142-171

Proprietary Name: Infants Gas Relief Dye Free 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 Antigas 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.

NDC Code Structure

  • 30142 - The Kroger Co.
    • 30142-171 - Infants Gas Relief

NDC 30142-171-01

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

NDC Product Information

Infants Gas Relief Dye Free with NDC 30142-171 is a a human over the counter drug product labeled by The Kroger Co.. The generic name of Infants Gas Relief Dye Free is simethicone antigas. The product's dosage form is emulsion and is administered via oral form.

Labeler Name: The Kroger Co.

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.

Infants Gas Relief Dye Free 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.

  • DIMETHICONE 20 mg/.3mL

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, UNSPECIFIED FORM (UNII: K679OBS311)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MICROCRYSTALLINE CELLULOSE (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: The Kroger Co.
Labeler Code: 30142
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: 07-16-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Infants Gas Relief Dye Free Product Label Images

Infants Gas Relief Dye Free 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. •all dosages 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 or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. •dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids •clean dropper well after each use-recap bottle with original cap •mL = milliliterAge (yr)Weight (lb)Dose (mL)infants under 2under 240.3children 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

* Please review the disclaimer below.

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