Cvs
FDA Label NDC 59779-867

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs (NDC 59779-867). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

(in each prefilled bottle)

Sodium Bicarbonate USP 700 mg }

Sodium Chloride USP 2300 mg }

Active ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg }

Sodium Chloride USP 2300 mg }

Otc - Purpose

Purpose

Nasal Wash

Purpose

Nasal Wash

Indications & Usage

Uses

Temporarily relieves symptoms associated with sinusitis, cold, flue 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 ear.

When using this product:

-Use by only one person

-Wash with soap and water after each use

-Do not heat in microwave


Otc - 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 packets per 8 fl oz (240 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.

Other Safety Information

Other information

  • inspect saline packets for integrity
  • Do not use saline packets if open or torn
  • Do not use if printed foil seal under cap on pre-filled bottle is broken or missing
  • Protect saline packets from excessive heat and moisture
  • See saline packets or box for lot number and expiration date

Inactive Ingredient

Inactive ingredients

(in each prefilled bottle)

Purified Water USP, Benzalkonium Chloride USP (Preservative)

Inactive ingredient

(in each packet)

none

Otc - Questions

Questions?

1-888-547-5492

Package Label.Principal Display Panel

Copy Of Label (Rtu Kit)

Copy Of Label (Rtu Kit)

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