NDC 21130-015 Signature Care Infants Gas Relief

Simethicone

NDC Product Code 21130-015

NDC 21130-015-10

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

NDC Product Information

Signature Care Infants Gas Relief with NDC 21130-015 is a a human over the counter drug product labeled by Safeway. The generic name of Signature Care Infants 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.

Signature Care Infants 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • 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: Safeway
Labeler Code: 21130
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: 09-04-2015 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: 12-31-2021 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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Signature Care Infants 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 symptoms of gas frequently caused by air swallowing or certain formulas or foods

When Using This Product

Do not exceed 12 doses per day

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 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 to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek •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 capAge (yr)Weight (lb)Doseinfants under 2under 240.3 mLchildren over 2over 240.6 mL

Other Information

  • •store at 20-25°C (68-77°F) •do not use if printed bottle wrap is broken or missing

Inactive Ingredients

Anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions?

1-888-723-3929

* Please review the disclaimer below.