Active Ingredients
Sodium Chloride 2860 MG .......................................... Nasal Wash and Cleaning
Bicarbonate 65 MG ..................................................... Nasal Wash and Cleaning
Burble Tablet, For Solution
FDA Label NDC 83557-001
12 label sections · Submitted to the FDA by Lets Burble, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lets Burble, Inc. for the product Burble (NDC 83557-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, use, warnings, otc - do not use, otc - stop use, keep out out of reach of children, other infomation, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
Do not use tablets if open or torn
Otc - Stop Use
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?
Other
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 (Burble Front)
Back (Burble Bckpng)
* Please review the disclaimer below.
