SOFT TIP SQUEEZE BOTTLE SINUS WASH PREMIER VALUE- sodium bicarbonate, sodium chloride kit

Soft Tip Squeeze bottle Sinus Wash by

Drug Labeling and Warnings

Soft Tip Squeeze bottle Sinus Wash by is a Otc medication manufactured, distributed, or labeled by Premier Value. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Purpose

Nasal Wash

ACTIVE INGREDIENT

Active ingredients

(in each packet)

Sodium Bicarbonate USP (700 mg)

Sodium Chloride USP (2300 mg)

INDICATIONS & USAGE

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies

-Sneezing

-Nasal Stuffiness

-Runny nose

-Post nasal drip

Removes inhaled irritants (dust, pollen)

Removes nasal and sinus drainage

Helps reduce swelling of nasal membranes

Moisturizes dry nasal passages

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS

Warnings

Stop use and ask a doctor if washing is uncomfortable

or symptoms are not relieved.

Do not use unfiltered tap water. see instructions inside box for proper water sources

Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

DOSAGE & ADMINISTRATION

Directions

Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every 2 hours as needed.

Children under 4 years: Consult a physician

See enclosed instruction sheet for complete directions and proper use.

OTHER SAFETY INFORMATION

Other Information

-Inspect saline packets for integrity

-Do not use saline packets if open or torn

-Protect saline packets from excessive heat and moisture

-See saline packets or box for lot number and expiration date

Questions?

1-888-547-5492

INACTIVE INGREDIENT

Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFT TIP SQUEEZE BOTTLE SINUS WASH  PREMIER VALUE
sodium bicarbonate, sodium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-452

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-452-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	01/09/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	30 PACKET	90000 mg

Part 1 of 1

SINUS WASH SALINE REFILLS 
sodium bicarbonate, sodium chloride powder, for solution

Product Information
Item Code (Source)	NDC: 42829-998
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	2300 mg  in 3000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	700 mg  in 3000 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42829-998-00	3000 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/09/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/09/2022

Labeler - Premier Value (101668460)