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SinuCleanse by ASCENT CONSUMER PRODUCTS, INC.

Dosage form: powder, for solution
Ingredients: SODIUM BICARBONATE 22.2mg in 100mg, SODIUM CHLORIDE 77.8mg in 100mg
Labeler: ASCENT CONSUMER PRODUCTS, INC.
NDC Code: 42829-408

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Facts

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Purpose

Nasal Wash

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

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 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

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 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 Ingredients

None

Questions?

1-888-547-5492

SINUCLEANSE  
sodium bicarbonate, sodium chloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-408
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (SODIUM CATION and BICARBONATE ION) SODIUM BICARBONATE22.2 mg  in 100 mg
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE77.8 mg  in 100 mg
Packaging
#Item CodePackage Description
1NDC:42829-408-00100 PACKET (PACKET) in 1 CARTON
13000 mg in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2015
Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)
Establishment
NameAddressID/FEIOperations
ASCENT CONSUMER PRODUCTS, INC.078396381manufacture(42829-408)

Revised: 02/2015
 
ASCENT CONSUMER PRODUCTS, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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