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Gas relief maximum strength - Medication Information

Product NDC Code 69168-434
Drug Name

Gas relief maximum strength

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 250 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 412111
Application Number M002
Labeler Name Allegiant Health
Packages
Package NDC Code Description
69168-434-01 100 capsule, liquid filled in 1 bottle (69168-434-01)
69168-434-50 50 capsule, liquid filled in 1 bottle (69168-434-50)
69168-434-98 200 capsule, liquid filled in 1 bottle (69168-434-98)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient(s) Simethicone 250 mg

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 1 or 2 softgels as symptoms occur Do not exceed 2 softgels in 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 D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink

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(s) 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 Maximum Strength Simethicone DIMETHICONE DIMETHICONE D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN GLYCERIN WATER PC31

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 Gas Relief Gas Relief

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 (59°– 86°F) 15°– 30°C do not use if imprinted safety seal under cap is broken or missing

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 1-888-952-0050 Monday through Friday 9AM - 5PM

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 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 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