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| Product NDC Code | 80513-112 | ||||
|---|---|---|---|---|---|
| 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 | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 412111 | ||||
| Application Number | M002 | ||||
| Labeler Name | Advanced Rx 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 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 adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 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 D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.
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.Gas Relief Simethicone D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN GLYCERIN WATER DIMETHICONE DIMETHICONE Transparent Purple PC31
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 80513-112-01 Compare to the active ingredient in Maximum Strength Gas-X ®† HIGH POTENCY GAS RELIEF Simethicone 250 mg • RELIEVES GAS FAST • PRESSURE • BLOATING • DISCOMFORT 100 SOFTGELS †This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ® Carton
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
Distributed by: Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if condition persists
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.If pregnant or breast-feeding, ask a health professional before use. 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 1-800-630-8895
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 DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
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