SINUCLEANSE- sodium bicarbonate, sodium chloride powder, for solution

SinuCleanse by

Drug Labeling and Warnings

SinuCleanse by is a Otc medication manufactured, distributed, or labeled by ASCENT CONSUMER PRODUCTS, INC.. 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

-Runny nose

-Nasal stuffiness

-Post nasal drip

-Removes inhaled irritants (dust, pollen)

-Promotes nasal and sinus drainage

-Helps reduce swelling of nasal membranes

-Moisturizes dry nasal passages

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.

WHEN USING

When using this product:

-Use by only one person

-Wash with soap and water after each use

-Top rack of dishwasher safe

-Do not heat in microwave

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions

Adults and children 4 years and over:      use 1/2 - 1 packet per 4 fl oz (120 mL)up to every two 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 # and expiration date

INACTIVE INGREDIENT

Inactive Ingredients

None

QUESTIONS

Questions?

1-888-547-5492

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINUCLEANSE 
sodium bicarbonate, sodium chloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42829-408
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	22.2 mg  in 100 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	77.8 mg  in 100 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42829-408-00	100 in 1 CARTON	12/01/2015
1		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		02/01/2015

Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)

Establishment
Name	Address	ID/FEI	Business Operations
ASCENT CONSUMER PRODUCTS, INC.		078396381	manufacture(42829-408)