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Gas relief - Medication Information

Product NDC Code 70000-0514
Drug Name

Gas relief

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 250 mg/1
Route ORAL
Dosage Form CAPSULE, GELATIN COATED
RxCUI drug identifier 412111
Application Number M002
Labeler Name Cardinal Health
Packages
Package NDC Code Description
70000-0514-1 1 bottle in 1 carton (70000-0514-1) / 60 capsule, gelatin coated in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each softgel) Simethicone 250mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions swallow one or two softgels as symptoms occur do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Information about the drug product’s indications for use.
Purpose Anti-gas

Spl product data elements

Usually a list of ingredients in a drug product.
Gas Relief Simethicone DIMETHICONE DIMETHICONE D&C RED NO. 33 WATER GELATIN, UNSPECIFIED FD&C BLUE NO. 1 GLYCERIN TITANIUM DIOXIDE 60ct-bottle-lbl 60ct-carton-lbl

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Cardinal Health - Leader Maximum Strength Gas Relief Simethicone 250 mg (anti-gas) 60 Liquid Filled Softgels Bottle label NDC# 70000-0514-1 Principal Display Panel Cardinal Health - Leader Maximum Strength Gas Relief Simethicone 250 mg (anti-gas) 60 Liquid Filled Softgels Carton NDC# 70000-0514-1

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other Information store at room temperature 15ºC to 30ºC (59ºF to 86ºF)

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call toll-free 1-800-706-5575

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if Stop use and ask a doctor if condition persists

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Stop use and ask a doctor if Stop use and ask a doctor if condition persists Keep out of reach of children.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API