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| Product NDC Code | 70000-0632 | ||||
|---|---|---|---|---|---|
| Drug Name | Maximum strength gas relief softgel |
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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 | 412111 | ||||
| Application Number | M002 | ||||
| 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 softgel) Simethicone 250 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 • Swallow one or two softgels as symptoms occur • do not exceed 2 softgels per 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 D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water
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 • relieves bloating, pressure or fullness commonly referred to as gas
Purpose
Information about the drug product’s indications for use.Purpose Anti-gas
Spl product data elements
Usually a list of ingredients in a drug product.Maximum Strength Gas Relief Softgel Simethicone DIMETHICONE DIMETHICONE D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN WATER 813
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.Packaging Cardnl-antigas-0632
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
LEADER ™ Relieves: Bloating Pressure Fullness COMPARE TO PHAZYME ® MAXIMUM STRENGTH active ingredient* 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme ® Maximum Strength. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners. Product of United Arab Emirates
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? 1-888-577-8033 Monday- Friday 8am - 4pm EST
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature 20-25°C (68-77°F) • protect from heat, humidity and light
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 Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health professional before use. 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