NDC 73921-025 L-oral Gas Relief Drops

Simethicone

NDC Product Code 73921-025

NDC Product Information

L-oral Gas Relief Drops with NDC 73921-025 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of L-oral Gas Relief Drops is simethicone. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Global Pharma Healthcare Private Limited

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

L-oral Gas Relief Drops 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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • 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: Global Pharma Healthcare Private Limited
Labeler Code: 73921
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: 04-01-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

L-oral Gas Relief Drops Product Label Images

L-oral Gas Relief Drops 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

Anti-flatulence

Uses

Relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product Do not exceed 12 doses per day

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 immediately.

Directions

• Shake well before using  • All dosages may be repeated as needed, after meals and at bedtime • Fill enclosed dropper to recommended dosage level • Dispense liquid slowly into baby's mouth, toward the inner cheek • May mix with 1 oz. of cool water, infant formula or other suitable liquids • Clean dropper after each use and close the bottle to maintain child resistanceAge (yr)Weight (lb) Dose Infants under 2 Under 24 0.3 mL Children over 2 Over 24 0.6 mL

Other Information

Store at room temperature

Inactive Ingredients

Benzoic acid, Flavor, Magnesium aluminum silicate, Purified water, Simethicone emulsion, Sorbitol, Xanthan gum

* Please review the disclaimer below.