Xtreme Saline Rinse Mix

Xtreme Saline Rinse Mix
SPL v2
SPL
SPL Set ID 776f417e-e443-4918-8c7a-1913b7dddcd4
Route
NASAL
Published
Effective Date 2025-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (16.5 g) Chloride Ion (49.5 g)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-07-01

Description

Sodium Bicarbonate 16.5 g Sodium Chloride 49.5 g

Purpose

Nasal Wash


Medication Information

Purpose

Nasal Wash

Description

Sodium Bicarbonate 16.5 g Sodium Chloride 49.5 g

Uses

May relieve symptoms associated with

• allergies • post-nasal drip

• common cold • Nasal congestiom

Warnings

Directions
  • Use 1 packet per 200 ML as needed
Adults and children 4 years and over: Use 1-2 packets per 8 oz container every 2 hours as needed
Children under 4 years Consult a physician

Read Instructions for Use inside box for proper use

Drug Facts

Questions?

1-844-777-9601

Active Ingredient

Sodium Bicarbonate 16.5 g

Sodium Chloride 49.5 g

Other Information
  • Inspect saline solution packets for integrity
  • Do not use if open or torn
  • Protect saline solution packet from excessive heat and moisture
Package Labeling:

Inactive Ingredients

None

Keep Out of Reach of Children

Stop Use and Consult A Health

care provider if washing is uncomfortable or symptoms not relieved or worsen after nasal rinsing, especially if fever, nosebleed, or headaches are present.


Structured Label Content

Uses

May relieve symptoms associated with

• allergies • post-nasal drip

• common cold • Nasal congestiom

Purpose

Nasal Wash

Warnings

Directions
  • Use 1 packet per 200 ML as needed
Adults and children 4 years and over: Use 1-2 packets per 8 oz container every 2 hours as needed
Children under 4 years Consult a physician

Read Instructions for Use inside box for proper use

Drug Facts

Questions?

1-844-777-9601

Active Ingredient (Active ingredient)

Sodium Bicarbonate 16.5 g

Sodium Chloride 49.5 g

Other Information (Other information)
  • Inspect saline solution packets for integrity
  • Do not use if open or torn
  • Protect saline solution packet from excessive heat and moisture
Package Labeling:

Inactive Ingredients (Inactive ingredients)

None

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

Stop Use and Consult A Health (Stop use and consult a health)

care provider if washing is uncomfortable or symptoms not relieved or worsen after nasal rinsing, especially if fever, nosebleed, or headaches are present.


Advanced Ingredient Data


Raw Label Data

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