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| Product NDC Code | 81362-302 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength simethicone antigas 125 mg |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, GELATIN COATED | ||||
| RxCUI drug identifier | 198852 | ||||
| Application Number | M002 | ||||
| Labeler Name | LLS HEALTH LLC | ||||
| 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 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