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| Product NDC Code | 70000-0434 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader 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 | 314216 | ||||
| Application Number | part332 | ||||
| Labeler Name | CARDINAL HEALTH 110, LLC. DBA LEADER | ||||
| 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 tablet) Simethicone 80 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 chew 2 to 4 tablets thoroughly as needed after meals and at bedtime do not exceed 6 tablets per day unless directed by a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.
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(S) relieves: pressure bloating symptoms 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.Leader Gas relief Simethicone DIMETHICONE DIMETHICONE SUGARCANE MALTODEXTRIN DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SORBITOL G103
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 NDC 70000-0434-1 LEADER ™ Gas Relief Simethicone, 80 mg Antigas Mint Flavor For Relief of : Pressure, Bloating, Symptoms Referred to as Gas 100 CHEWABLE TABLETS 119
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 In case of overdose, get medical help or contact a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION do not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o 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 .
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