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]

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 -1 packet  per 4 fl oz (120 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.

SPL UNCLASSIFIED SECTION

Important Note: SinuCleanse Saline Packets contain 3 grams of

pharmaceutical grade salt. Using the calculations in the chart, you can

prepare either an Isotonic or Hypertonic Solution. Since contents of other

manufacturer's Salt Packets may vary, please check with their directions

for Isotonic or Hypertonic use.

ACTIVE INGREDIENT

Active ingredients

(in each packet)

Sodium Bicarbonate USP (700 mg)

Sodium Chloride USP (2300 mg)

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 enclosed instruction sheet for complete directions and proper use

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: 42829-401
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: 42829-401-01	3000 mg in 1 PACKET; Type 0: Not a Combination Product	02/01/2015

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(42829-401)