SINUS WASH SALINE REFILLS PREMIER VALUE- sodium bicarbonate, sodium chloride powder, for solution

Sinus Wash Saline Refills by

Drug Labeling and Warnings

Sinus Wash Saline Refills by is a Otc medication manufactured, distributed, or labeled by PREMIER VALUE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

(in each packet)

Sodium Bicarbonate USP (700 mg)

Sodium Chloride USP (2300 mg)

PURPOSE

Purpose

Nasal Wash

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.

INACTIVE INGREDIENT

Inactive ingredients

None

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 # and expiration date

QUESTIONS

Questions?

1-888-547-5492

OTHER SAFETY INFORMATION

-See instruction sheet for use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-251
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	700 mg  in 3000 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	2300 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: 68016-251-10	100 in 1 CARTON	01/08/2022
1	NDC: 68016-251-01	3000 mg in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/08/2022

Labeler - PREMIER VALUE (101668460)