Label: MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL- oxymetazoline hydrochloride solution
- NDC Code(s): 63824-129-17
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
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
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
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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.
- Other information
-
Inactive ingredients
benzalkonium chloride,
benzododecinium chloride,
camphor, cetalkonium chloride,
colloidal silicon dioxide, edetate
disodium, eucalyptol, glycine,
linoleic acid, linolenic acid,
menthol, myristalkonium
chloride, myristic acid, oleic
acid, palmitic acid, palmitoleic
acid, polyethylene glycol,
polysorbate 80, propylene glycol,
purified water, sodium
carbonate, sodium chloride,
sodium hydroxide, stearic acid
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
-
INGREDIENTS AND APPEARANCE
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL
oxymetazoline hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-129 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) GLYCINE (UNII: TE7660XO1C) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-129-17 1 in 1 CARTON 10/01/2018 1 22 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2018 Labeler - RB Health (US) LLC (081049410)
