Saline Refills

Manufacturer
Cardinal Health 414, LLC
Effective date
2013-05-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:40:49

Label at a glance#

ProductSaline Refills
Active ingredientSODIUM BICARBONATE, SODIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Purpose

Nasal Wash

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves symptoms associated with sinusitis, cold, flu  or allergies

-Sneezing

-Nasal stuffiness

-Runny nose

-Post nasal drip

Removes inhaled irritants (dust, pollen)

Promotes nasal and sinus drainage

Helps reduce swelling of nasal membranes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach from children

WARNINGS SECTION

Warnings

Stop use and ask a  doctor if washing is uncomfortable or symptoms are not relieved

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 4 years and over: use 1-2 packets every 2 hours as needed

Children under 4 years: consult a doctor

Consult Instructions for Use for proper use

OTC - WHEN USING SECTION

 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

INSTRUCTIONS FOR USE SECTION

Instructions for Use

Directions: Read through entire section before using for the first time.

1. Empty the contents of one Saline Sinus Wash packet into the Classic Neti pot. First-time users should start with 1/2 of the dry ingredients.

As you become more accustomed to the system, work up to suing 1 full packet. Additional packets may be purchased from your nearest pharmacy.

2. Fill the pot halfway or to the middle of the indentation with proper water. This makes 1/2 cup (4 oz) solution.

3. Stir thoroughly until dry ingredients have completely dissolved.

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

-Lean over the sink so you are looking directly into the basin. Holding the 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 handle of the pot so that the

solution enters the right nostril. In a few moments, the solution will begin to drain out of the left nostril into the sink. Do no inhale or "snort" solution into the nose -

breathe through your mouth.

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

6. Repeat the procedure on the other side..

7. Thoroughly rinse the pot with water that has been distilled, sterilized, filtered or previously boiled and leave the pot to air dry completely.

The Classic Neti Pot is top-rack dishwasher safe.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

INACTIVE INGREDIENT SECTION

 Inactive Ingredients

None

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-753-782025-04-28C16284748780-19d75b9d0-67f6-f424-e053-dadaa90a57ceDrug Facts
37205-753-782020-01-31C16284748780-19d75b9d0-67f6-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-753-78EA - Each37205-753e1151d57-78db-4f3e-a790-115a989ef28312013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO4
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X4
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q204
SODIUM CATIONACTIVE MOIETYLYR4M0NH374

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-75337205-753-78

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33a1c0d0-3980-4194-b1ef-bf24cf755a91c9d8ef33-46ed-4c60-842c-7d23f12bfcb92025-04-23WarningsExact identifier
spl set id: c9d8ef33-46ed-4c60-842c-7d23f12bfcb9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.