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Extra strength simethicone antigas 125 mg - Medication Information

Product NDC Code 81362-302
Drug Name

Extra strength simethicone antigas 125 mg

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 125 mg/1
Route ORAL
Dosage Form CAPSULE, GELATIN COATED
RxCUI drug identifier 198852
Application Number M002
Labeler Name LLS HEALTH LLC
Packages
Package NDC Code Description
81362-302-20 220 capsule, gelatin coated in 1 bottle (81362-302-20)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) Simethicone 125 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 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, 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 for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Purpose

Information about the drug product’s indications for use.
Purpose Antigas

Spl product data elements

Usually a list of ingredients in a drug product.
EXTRA STRENGTH SIMETHICONE ANTIGAS 125 MG SIMETHICONE FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN GLYCERIN PEPPERMINT OIL POVIDONE WATER SORBITOL SOLUTION 70% TITANIUM DIOXIDE DIMETHICONE DIMETHICONE YH3

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.
Package Labeling: 01b LBL_W-W_Simethicone_125mg_220ct_PDP 01b LBL_W-W_Simethicone_125mg_220ct_DF

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 1-844-735-0202

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20° to 25°C (68° to 77°F) protect from light, heat and moisture

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 If pregnant or breast-feeding, ask a health professional before use.

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