Burble Salt Tablets, 30ct (83557-001-30)

Burble Salt Tablets, 30ct (83557-001-30)
SPL v3
SPL
SPL Set ID 17f48d4f-907c-3829-e063-6394a90ab202
Route
NASAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (2860 mg) Bicarbonate Ion (65 mg)
Inactive Ingredients
Anhydrous Citric Acid Povidone K90 Polyethylene Glycol 8000

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-08

Description

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


Medication Information

Description

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

Pdp

Burble Salt Tablets (83557-001-30)

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
Section 42229-5

Manufactured for Let’s Burble Inc., 1607 Ponce

De Leon STE GM6 PMB 565San Juan, PR 00909

FOR NASAL IRRIGATION USE ONLY

Section 50566-9

In case of eye contact, promptly irrigate eye with water for 10 minutes. Seek medical attention if irritation persists.

Section 50570-1

Do not use tablets if open or torn

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
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

Questions?
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
Active Ingredients

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

Bicarbonate 65 MG ..................................................... Nasal Wash and Cleaning

Inactive Ingredients

citric acid, polyethylene glycol, Polyvinylpyrrolidone K-90

Keep Out Out of Reach of Children

Consult a Physician


Structured Label Content

Pdp (PDP)

Burble Salt Tablets (83557-001-30)

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
Section 42229-5 (42229-5)

Manufactured for Let’s Burble Inc., 1607 Ponce

De Leon STE GM6 PMB 565San Juan, PR 00909

FOR NASAL IRRIGATION USE ONLY

Section 50566-9 (50566-9)

In case of eye contact, promptly irrigate eye with water for 10 minutes. Seek medical attention if irritation persists.

Section 50570-1 (50570-1)

Do not use tablets if open or torn

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
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

Questions?
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
Active Ingredients

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

Bicarbonate 65 MG ..................................................... Nasal Wash and Cleaning

Inactive Ingredients

citric acid, polyethylene glycol, Polyvinylpyrrolidone K-90

Keep Out Out of Reach of Children (Keep out out of reach of children)

Consult a Physician


Advanced Ingredient Data


Raw Label Data

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