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| Product NDC Code | 69618-032 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone 125 mg |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 314221 | ||||
| Application Number | part332 | ||||
| Labeler Name | Reliable 1 Laboratires 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 chewable tablet) 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 thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more than 4 tablets per day
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid
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 and fullness commonly referred to as gas
Purpose
Information about the drug product’s indications for use.Antiflatulent
Spl product data elements
Usually a list of ingredients in a drug product.Simethicone 125 mg Simethicone SUCROSE DIMETHICONE DIMETHICONE MALTODEXTRIN PEPPERMINT SORBITOL STEARIC ACID DEXTROSE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE Off white AP;040
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.NDC 69618-032-06 Simethicone 125 mg ANTIFLATULENT 60 CHEWABLE TABLETS *Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH Simethicone 125mg
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
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Mylanta® Distributed by: Reliable 1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com
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 516-341-0666, 8:30 am -4:30 pm ET, Monday - Friday
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 15°-30°C (59°-86°F)
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 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