NDC 37012-550 Extra Strength Gas Relief

NDC Product Code 37012-550

NDC CODE: 37012-550

Proprietary Name: Extra Strength 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: 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):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
PO
Score: 1

NDC Code Structure

  • 37012 - Shopko Stores Operating Co., Llc.

NDC 37012-550-30

Package Description: 2 BLISTER PACK in 1 CARTON > 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Extra Strength Gas Relief with NDC 37012-550 is a product labeled by Shopko Stores Operating Co., Llc.. The generic name of Extra Strength Gas Relief is . The product's dosage form is and is administered via form.

Labeler Name: Shopko Stores Operating Co., Llc.

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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

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

Labeler Name: Shopko Stores Operating Co., Llc.
Labeler Code: 37012
Start Marketing Date: 06-02-2010 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: 12-31-2019 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".

* Please review the disclaimer below.

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]

* Please review the disclaimer below.

Extra Strength Gas Relief Product Label Images

Extra Strength 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)

Simethicone 125 mg

Purpose

Antiflatulent

Uses

  • For relief of:bloatingpressurefullnessstuffed feeling commonly referred to as gas

Stop Use And Ask A Doctor If

Condition persists.

If Pregnant Or Breast- Feeding

Ask a health care professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor.

Other Information

  • Store at controlled room temperature 15o- 30o C (59o- 86o F)protect from heat and moisture*This product is not manufactured or distributed by Novartis Consumer Healthcare Inc., owner of the registered trademark Extra Strength Gas-X®.

Inactive Ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special.

Product Label

SIMETHICONE 125 MG

* Please review the disclaimer below.