Rite Aid Sinus Wash Pre-mixed Ready To Use

Rite Aid Sinus Wash Pre-mixed Ready To Use
SPL v7
SPL
SPL Set ID d5b34dfd-e2bb-e666-e053-2a95a90a29fa
Route
NASAL
Published
Effective Date 2016-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (77.8 mg) Sodium Cation (22.8 mg)
Inactive Ingredients
Water Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-01-16

Description

Active Ingredients (in each prefilled bottle) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 2300 mg


Medication Information

Warnings and Precautions

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
  • Do not heat in microwave

Indications and 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

Dosage and 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

Prior to first use see enclosed instruction sheet for complete directions

Description

Active Ingredients (in each prefilled bottle) Sodium Bicarbonate USP 700 mg Sodium Chloride USP 2300 mg

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

(in each prefilled bottle)

Purified Water USP, Benzalkonium Chloride USP (Preservative)

Inactive ingredients

(in each packet)

None

Section 51945-4

Section 53413-1

Questions?

1-888-547-5492

Section 55105-1

Purpose

Nasal Wash

Section 55106-9

Active Ingredients

(in each prefilled bottle)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Section 60561-8

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 no. and expiration date


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Prior to first use see enclosed instruction sheet for complete directions

Warnings and Precautions (34071-1)

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
  • Do not heat in microwave

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

(in each prefilled bottle)

Purified Water USP, Benzalkonium Chloride USP (Preservative)

Inactive ingredients

(in each packet)

None

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

1-888-547-5492

Section 55105-1 (55105-1)

Purpose

Nasal Wash

Section 55106-9 (55106-9)

Active Ingredients

(in each prefilled bottle)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Section 60561-8 (60561-8)

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 no. and expiration date


Advanced Ingredient Data


Raw Label Data

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