BURBLE- sodium chloride tablet, for solution

BURBLE by

Drug Labeling and Warnings

BURBLE by is a Otc medication manufactured, distributed, or labeled by LETS BURBLE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

BURBLE 
sodium chloride tablet, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83557-001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	2860 mg
CALCIUM BICARBONATE (UNII: 7PRA4BLM2L) (BICARBONATE ION - UNII:HN1ZRA3Q20)	CALCIUM BICARBONATE	65 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POVIDONE K90 (UNII: RDH86HJV5Z)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83557-001-30	30 in 1 BAG; Type 1: Convenience Kit of Co-Package	05/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	05/08/2024

Labeler - LETS BURBLE, INC. (119182610)