Otc - Active Ingredient
Naphazoline hydrochloride 0.05% v/v. Purpose: Nasal decongestant
Nafasolina Solution/ Drops
FDA Label NDC 12539-146
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doral Pharmamedics Inc Dba Ag Marin Pharmaceuticals for the product Nafasolina (NDC 12539-146). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - keep out of reach of children, inactive ingredient, otc - purpose, otc - when using, dosage & administration, warnings, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Stop using this product after 3 days.
If symptoms persist, stop, and consult a doctor.
Inactive Ingredient
Benzalkonium chloride, purified water, sodium bisulfite, sodium chloride, and sodium citrate.
Otc - Purpose
For the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.
Temporarily relieves a stuffy nose.
Helps clear nasal passages.
Otc - When Using
Use for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.
Dosage & Administration
Adults and children 12 years of age and over: 1 or 2 drops in each nostril not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.
Warnings
Do not exceed recommended dosage.
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.
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. If symptoms persist, consult a doctor.
Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Do not use this product in children under 12 years of age because it may cause sedation if swallowed.
When using this product avoid contact with the eyes.
Otc - Do Not Use
If you are pregnant or breast-feeding consult a health care professional before using this product.
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2
weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.
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. If symptoms persist, consult a doctor.
Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Do not use this product in children under 12 years of age because it may cause sedation if swallowed.
Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
This product is for nasal use only.
When using this product avoid contact with the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Indications & Usage
Naphazoline hydrochloride 0.05% nasal drops are indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis. Temporarily relieves a stuffy nose. Helps clear nasal passages.
Package Label.Principal Display Panel
Nafasolina-drug-facts-box (Nafasolina Drug Facts Box)
0.5 FL. OZ NDC: 12539-146-02
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