Mucinex® Sinus-max®

Mucinex® Sinus-max®
SPL v5
SPL
SPL Set ID 41b8cead-92a0-47d8-8079-4fb5d18bf249
Route
NASAL
Published
Effective Date 2022-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Glycerin Sodium Phosphate, Monobasic, Unspecified Form Propylene Glycol Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifsymptoms persist

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: consult a doctor.

Shake well before use.



To open, hold by the white grips then squeeze, push

down firmly and turn cap counterclockwise. Before

using for the first time, remove the protective cap from

the tip and prime metered pump by depressing firmly

several times. To spray, hold bottle with thumb at the

base and nozzle between first and second fingers.

Without tilting head, insert nozzle into nostril. Fully

depress pump all the way down with a firm even

stroke and sniff deeply. Wipe nozzle

clean after use. To close, turn cap

clockwise.

DO NOT DISCARD CAP.

Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this number.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients



benzalkonium chloride,

benzododecinium chloride,

cetalkonium chloride, dibasic

sodium phosphate anhydrous,

edetate disodium, glycerin,

monobasic sodium phosphate

anhydrous, myristalkonium

chloride, phosphorous pentoxide,

propylene glycol, purified water,

sodium oxide, sorbitol

When Using This Product
  • do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Principal Display Panel 22 Ml Bottle Carton

NDC 63824-120-11

Mucinex®

SINUS-MAX®

SEVERE

NASAL CONGESTION

RELIEF

SINUS & ALLERGY

NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

  • Fast acting
  • Lasts 12 Hours

3/4 FL OZ (22 mL)


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsymptoms persist

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Nasal decongestant

Directions
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: consult a doctor.

Shake well before use.



To open, hold by the white grips then squeeze, push

down firmly and turn cap counterclockwise. Before

using for the first time, remove the protective cap from

the tip and prime metered pump by depressing firmly

several times. To spray, hold bottle with thumb at the

base and nozzle between first and second fingers.

Without tilting head, insert nozzle into nostril. Fully

depress pump all the way down with a firm even

stroke and sniff deeply. Wipe nozzle

clean after use. To close, turn cap

clockwise.

DO NOT DISCARD CAP.

Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this number.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)



benzalkonium chloride,

benzododecinium chloride,

cetalkonium chloride, dibasic

sodium phosphate anhydrous,

edetate disodium, glycerin,

monobasic sodium phosphate

anhydrous, myristalkonium

chloride, phosphorous pentoxide,

propylene glycol, purified water,

sodium oxide, sorbitol

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Principal Display Panel 22 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton)

NDC 63824-120-11

Mucinex®

SINUS-MAX®

SEVERE

NASAL CONGESTION

RELIEF

SINUS & ALLERGY

NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

  • Fast acting
  • Lasts 12 Hours

3/4 FL OZ (22 mL)


Advanced Ingredient Data


Raw Label Data

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