Label: BURBLE- sodium chloride tablet, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2024

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  • Drug Facts

  • Active Ingredients

    Sodium Chloride 2860 MG .......................................... Nasal Wash and Cleaning
    Bicarbonate 65 MG ..................................................... Nasal Wash and Cleaning

  • 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
  • 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

  • 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
  • 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 Ingredients

    citric acid, polyethylene glycol, Polyvinylpyrrolidone K-90

  • Questions?

    support@letsburble.com

  • SPL UNCLASSIFIED SECTION

    Manufactured for Let’s Burble Inc., 1607 Ponce
    De Leon STE GM6 PMB 565San Juan, PR 00909
    FOR NASAL IRRIGATION USE ONLY

  • PDP

    Burble Salt Tablets (83557-001-30)

    front

    back

  • INGREDIENTS AND APPEARANCE
    BURBLE 
    sodium chloride tablet, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83557-001
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2860 mg
    CALCIUM BICARBONATE (UNII: 7PRA4BLM2L) (BICARBONATE ION - UNII:HN1ZRA3Q20) CALCIUM BICARBONATE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83557-001-3030 in 1 BAG; Type 1: Convenience Kit of Co-Package05/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01805/08/2024
    Labeler - LETS BURBLE, INC. (119182610)
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