CVS- sodium chloride, sodium bicarbonate kit

CVS by

Drug Labeling and Warnings

CVS by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, 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 reduced.

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

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 2 hours as needed

Children under 4 years:  Consult a physician

See enclosed instruction sheet for complete instructions 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
  

INACTIVE INGREDIENT

Inactive ingredients: none

QUESTIONS

Questions?

1-888-547-5492

INSTRUCTIONS FOR USE

*IMPORTANT NOTE
Do not sinus wash with unfiltered tap water. Use either distilled, or sterile, or filtered (using a filter with an absolute pore size of 1 micron orsmaller) or previously boiled water (boil water 1 minute or 3 minutes if at elevations above 6,500 feet then allow to cool to bodytemperature).

Sinus Wash Compact Neti Pot Instructions
Read through entire instruction
sheet before using for the first time.

DO NOT SINUS WASH
WITH UNFILTERED TAP WATER.
See important note* for proper water sources.

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

Should I use an Isotonic or Hypertonic Solution?

Any Sinus Wash Device can be used with the enclosed Saline packets to make either an Isotonic or Hypertonic solution. Check with the guide below or consult with your physician for best use.

Isotonic Solution 1/2 Saline Packet per 4 fl oz. (120 mL)

Hypertonic Solution 1 Saline Packets per 4 fl oz. (120 mL)

An Isotonic solution creates a mild, less concentrated salt solution of 9 mg of Sodium Chloride per mL of water, which has a similar salt concentration of your body and may be more comfortable to use for some people initially than a more concentrated Hypertonic solution.

A Hypertonic solution creates a higher, more concentrated salt solution which is similar to the salt content of ocean water.

What is the Sinus Wash System?
The Sinus Wash System is an all natural and medically proven method for relieving allergies, nasal congestion, discomfort caused by dry air, sinus infections, rhinitis of pregnancy and
soothing irritated nasal passages. It gently washes away mucus buildup from the nose and improves breathing.
Because it is gentle, the system can be used up to every 2 hours as needed. Some people use it as routinely as they brush their teeth while others use it only on days when they need it.

ACP No. 99-40330-205-00

Instructions for Use of the Compact Neti Pot:
Directions & Dosage: Read through entire section before using for the first time.

1. Pour the pre-mixed saline dry ingredients into the Compact Neti Pot. First-time users should start with 1/2 packet of the saline dry
ingredients. As you become more accustomed to the system, work up to using 1 full packet. Additional packets may be purchased from your nearest pharmacy.

2. Fill the pot to the 4 oz. line with proper water*. This makes 1/2 cup (4 oz.) of solution.

3. Stir thoroughly until the dry ingredients have completely dissolved.

4. Proper head position allows solution to flow through the nose by gravity.

Lean over the sink with your head bent down so you are looking directly into the basin. Holding the Neti Pot in your right hand, gently insert the spout into your right nostril so that it forms a comfortable seal.

Rotate your head so that the right nostril is directly above the left. The forehead should remain higher than the chin. Raise the Neti Pot so that the solution enters the right nostril. In a few moments, the solution will begin to drain out the left nostril into the sink. Do not inhale
or “snort” solution into the nose – breathe through your mouth.

5. When the Neti Pot is empty, exhale through both nostrils to clear them of excess mucus and solution. Gently blow your nose into a tissue.

6. Repeat the procedure on the left nostril.

7. Thoroughly rinse the Neti Pot after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the pot open to air dry completely. The Compact Neti Pot is top-rack dishwasher safe.

Hints for a more comfortable nasal wash:
Begin using the Sinus Wash System slowly – especially with children. A full pot of solution on each side is not necessary to receive the full benefit.
If the solution is too warm or too cold, the nasal wash will be uncomfortable.
If stinging or irritation occurs, try using 1/2 packet of dry ingredients per pot. Gradually work up to using the
solution at full strength using 1 full packet per pot. Do not use less than 1/2 packet.
If you experience ear discomfort after use, try to blow your nose more gently after the wash. If the problem persists, the openings of your Eustachian tubes may be particularly wide and use of the system should be discontinued.
Breathe continuously through the mouth when using the Sinus Wash System to avoid solution draining from the back of the nose into the mouth.
Some people experience irritation of the skin just inside the nostrils with repeated nasal washing. Applying a thin layer of aloe to the inside of the nostrils before or after the nasal wash will be soothing.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS 
sodium chloride, sodium bicarbonate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-349

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-349-10	1 in 1 KIT	03/25/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	3000 mg

Part 1 of 1

CVS 
sodium bicarbonate, sodium chloride powder

Product Information
Item Code (Source)	NDC: 69842-324
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	22.8 mg  in 100 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	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		10 in 1 KIT
1	NDC: 69842-324-01	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		06/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/25/2016

Labeler - CVS Pharmacy, Inc. (062312574)