NDC 0113-0657 Good Sense Gas Relief
Simethicone
NDC Product Code 0113-0657
Proprietary Name: Good Sense Gas Relief 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 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.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.
Product Characteristics
Color(s):
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
L657
Score: 1
NDC Code Structure
- 0113 - L. Perrigo Company
- 0113-0657 - Good Sense Gas Relief
NDC 0113-0657-72
Package Description: 1 BOTTLE in 1 CARTON > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE
Price per Unit: $0.05893 per EA
NDC Product Information
Good Sense Gas Relief with NDC 0113-0657 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Gas Relief is simethicone. The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 252294.
Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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.
Good Sense 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)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- GELATIN (UNII: 2G86QN327L)
- GLYCERIN (UNII: PDC6A3C0OX)
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.
Pharmacological Class(es)
What is a Pharmacological Class?These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: L. Perrigo Company
Labeler Code: 0113
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: 04-05-2002 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".
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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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Good Sense Gas Relief Product Label Images
Good Sense 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 Softgel)
- Purpose
- Use
- Stop Use And Ask A Doctor If
- Directions
- Other Information
- Inactive Ingredients
Active Ingredient (In Each Softgel)
Simethicone 180 mg
Purpose
Anti-gas
Use
- •relieves bloating, pressure or fullness commonly referred to as gas
Stop Use And Ask A Doctor If
Condition persists
Directions
- •swallow one or two softgels as needed after a meal •do not exceed two softgels per day except under the advice and supervision of a physician
Other Information
- •each softgel contains: potassium 5 mg •store at 68°-77°F (20°-25°C)
Inactive Ingredients
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin
* Please review the disclaimer below.