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| Product NDC Code | 80136-859 | ||||
|---|---|---|---|---|---|
| Drug Name | Gas relief |
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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 | M002 | ||||
| Labeler Name | Northeast Pharma | ||||
| 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 do not take more than directed chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime do not exceed 4 chewable tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate
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.Uses 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.Gas Relief Simethicone DIMETHICONE DIMETHICONE CROSPOVIDONE, UNSPECIFIED D&C RED NO. 27 ALUMINUM LAKE D&C RED NO. 30 ALUMINUM LAKE DEXTROSE MONOHYDRATE FD&C RED NO. 40 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE STARCH, CORN SUCRALOSE TRIBASIC CALCIUM PHOSPHATE DIMETHICONE 410 44;608
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 Heartland® Pharma Co. NDC 80136-859-68 Extra Strength GAS RELIEF Simethicone 125 mg Chewable Tablets Antigas Relieves Pressure Bloating Discomfort Compare to the active ingredient in Gas-X® Extra Strength* Chew or crush tablets completely before swallowing. 100 Chewable Tablets Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength. 50844 ORG122060812 Distributed by: NORTHEAST PHARMA Williston, VT 05495 www.heartlandpharmaco.com 1-800-383-0648 Heartland Pharma 44-608 Heartland Pharma 44-608
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? 1-800-383-0648
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 85 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture use by expiration date on package
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