NDC 63941-550 Gas Relief Extra Strength

NDC Product Code 63941-550

NDC CODE: 63941-550

Proprietary Name: Gas Relief Extra Strength 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.

Drug Use Information

Drug Use Information
The 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):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
PO
Score: 1

NDC Code Structure

  • 63941 - Valu Merchandisers Company (best Choice)

NDC 63941-550-30

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

Gas Relief Extra Strength with NDC 63941-550 is a product labeled by Valu Merchandisers Company (best Choice). The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 198852.

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)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Valu Merchandisers Company (best Choice)
Labeler Code: 63941
Start Marketing Date: 07-13-2010 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: 12-31-2017 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.

Gas Relief Extra Strength Product Label Images

Gas Relief Extra Strength 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 (Antigas)

Use

  • Relieves bloating, pressure, or fullness commonly referred to as gas.

Stop Using This Product 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 and at bedtime.
  • Do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.

Other Information

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

Inactive Ingredients

D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special and titanium dioxide.

Product Label

Simethicone 125 mg

* Please review the disclaimer below.