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NDC 63824-0120-11 MUCINEX SINUS-MAX 0.05 g/100mL Details
MUCINEX SINUS-MAX 0.05 g/100mL
MUCINEX SINUS-MAX is a NASAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is OXYMETAZOLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.
Related Packages: 63824-0120-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 63824-0120 |
|---|---|
| Product ID | 63824-120_e4536185-8c38-45d7-85a5-e6c81656533e |
| Associated GPIs | 42102040102010 |
| GCN Sequence Number | 008039 |
| GCN Sequence Number Description | oxymetazoline HCl SPRAY 0.05 % NASAL |
| HIC3 | Q7D |
| HIC3 Description | NOSE PREPARATIONS, VASOCONSTRICTORS(OTC) |
| GCN | 34062 |
| HICL Sequence Number | 003417 |
| HICL Sequence Number Description | OXYMETAZOLINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | MUCINEX SINUS-MAX |
| Proprietary Name Suffix | SEVERE CONGESTION RELIEF SINUS and ALLERGY |
| Non-Proprietary Name | Oxymetazoline Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | NASAL |
| Active Ingredient Strength | 0.05 |
| Active Ingredient Units | g/100mL |
| Substance Name | OXYMETAZOLINE HYDROCHLORIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0120-11 (63824012011)
| NDC Package Code | 63824-120-11 |
|---|---|
| Billing NDC | 63824012011 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (63824-120-11) / 22 mL in 1 BOTTLE, PUMP |
| Marketing Start Date | 2018-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 41b8cead-92a0-47d8-8079-4fb5d18bf249 Details
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
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 and turn cap. 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 until it "clicks".
DO NOT DISCARD CAP.
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| MUCINEX SINUS-MAX
SEVERE CONGESTION RELIEF SINUS AND ALLERGY
oxymetazoline hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |