Label: MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS AND ALLERGY- oxymetazoline hydrochloride solution
- NDC Code(s): 63824-120-11
- 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS AND ALLERGY
oxymetazoline hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-120 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) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-120-11 1 in 1 CARTON 11/01/2018 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 11/01/2018 Labeler - RB Health (US) LLC (081049410)
