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Product NDC Code | 70692-813 | ||||||
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Drug Name | Right remedies 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 | Strive Pharmaceuticals Inc. | ||||||
Packages |
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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 two 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 Antigas
Spl product data elements
Usually a list of ingredients in a drug product.Right Remedies 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 Strive-813
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
Compare to the active ingredient of Maximum Strength Phazyme ® * Fast relief of: bloating pressure fullness & gas TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE *This product is not manufactured or distributed by C.B. Fleet Company Inc., owner of the registered trademark Phazyme ® . DISTRIBUTED BY: Strive Pharmaceuticals Inc. East Brunswick, NJ 08816 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. Overdose warning : In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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 between 20-25°C (68-77°F) • protect from heat and moisture
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. Overdose warning : In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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