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| Product NDC Code | 55629-021 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone 125mg gas relief |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 198852 | ||||
| Application Number | M | ||||
| Labeler Name | One2Zee Limited Liability Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (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.D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, povidone, peppermint oil, purified water, sorbitol, 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 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.Simethicone 125MG Gas Relief Simethicone 125 mg DIMETHICONE DIMETHICONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN POVIDONE PEPPERMINT OIL WATER SORBITOL TITANIUM DIOXIDE Z25
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.Bottle-label
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.Drug Facts
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 or comments? Call 1-833-663-2933
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at controlled room temperature 20°-25°C (68°-77°F) protact from light, heat and moisture do not use if imprinted safety seal under cap is broken or missing
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.Warning 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