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Product NDC Code | 83557-001 | ||||
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Drug Name | Burble |
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Type | Brand | ||||
Pharm Class | Alkalinizing Activity [MoA] | ||||
Active Ingredients |
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Route | NASAL | ||||
Dosage Form | TABLET, FOR SOLUTION | ||||
Application Number | M018 | ||||
Labeler Name | LETS BURBLE, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Sodium Chloride 2860 MG .......................................... Nasal Wash and Cleaning Bicarbonate 65 MG ..................................................... Nasal Wash and Cleaning
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 For adults and children age 4 and above Dissolve 1 Burble tablet in 300mL of distilled water by shaking moderately for 6 seconds. Children under 4 years of age Consult a Physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients citric acid, polyethylene glycol, Polyvinylpyrrolidone K-90
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 Temporarily relieves symptons associated with sinusitis, cold, flu, allergies Including: Post nasal drip, sneezing, runny nose, nasal stuffiness Removes inhaled irritants, dust, pollen Helps reduce swelling of nasal membranes Moistens dry nasal passages Promotes nasal and sinus clearage
Purpose
Information about the drug product’s indications for use.Drug Facts
Spl product data elements
Usually a list of ingredients in a drug product.BURBLE SODIUM CHLORIDE SODIUM CHLORIDE CHLORIDE ION ANHYDROUS CITRIC ACID POVIDONE K90 POLYETHYLENE GLYCOL 8000 CALCIUM BICARBONATE BICARBONATE ION
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.PDP Burble Salt Tablets (83557-001-30) front back
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.Manufactured for Let’s Burble Inc., 1607 Ponce De Leon STE GM6 PMB 565San Juan, PR 00909 FOR NASAL IRRIGATION USE ONLY
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use tablets if open or torn
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 out of reach of children Consult a Physician
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Infomation Inspect individually wrapped tablets for integrity prior to use Do not use tablets if open or torn Store at room temperature away from water and direct sunlight Review to ensure tablets are not expired per expiration date on resealable bag and tablet wrapper
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.In case of eye contact, promptly irrigate eye with water for 10 minutes. Seek medical attention if irritation persists.
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 Prior to use read the detailed warnings and usage instruction for the Burble Nasal Irrigation Bottle included with the device or on our website at www.letsburble.com Use only Burble tablets in Burble Nasal Irrigation Bottle Do not use unfiltered tap water to dissolve tablets in Burble Nasal Irrigation bottle Do not use tablets if open or torn In case of eye contact, promptly irrigate eye with water for 10 minutes. Seek medical attention if irritation persists. Keep out out of reach of children Consult a Physician
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