LEADER SINUS WASH SALINE REFILLS- sodium bicarbonate, sodium chloride powder, for solution

Leader Sinus Wash Saline Refill Packets by

Drug Labeling and Warnings

Leader Sinus Wash Saline Refill Packets by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER. 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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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 for proper water sources.

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

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

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 # and expiration date

QUESTIONS

Questions?

1-888-547-5492

PATIENT PACKAGE INSERT

PATIENT PACKAGE INSERT

INACTIVE INGREDIENT

Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER  SINUS WASH SALINE REFILLS
sodium bicarbonate, sodium chloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0270
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	22.2 mg  in 100 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	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	NDC: 70000-0270-1	30 in 1 CARTON	04/01/2013
1		3000 mg in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 70000-0270-2	100 in 1 CARTON	04/01/2013
2		3000 mg in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2013

Labeler - Cardinal Health 414, LLC (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Ascent Consumer Products		078396381	manufacture(70000-0270)