Dosage and 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.
NAFASOLINA
- Manufacturer
- DUY DRUGS, INC | DEXTRUM LABORATORIES INC.
- Effective date
- 2021-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:38:08
Label at a glance#
ProductNAFASOLINA
Active ingredientNAPHAZOLINE HYDROCHLORIDE
Label structure14 sections
Storage and handling
Store between 15°-30°C (59°-86°F). Avoid exposing bottle to excessive heat and direct sunlight. Do not accept this product if safety seal is broken or missing. Keep box for information.
Label contents#
Full prescribing information#
Active Ingredient(s)
Naphazoline hydrochloride 0.05% v/v. Purpose: Nasal decongestant
Purpose
For the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.
Temporarily relieves stuffy nose.
Helps clear nasal passages.
Use
For the temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.
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.
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.
OTC - WHEN USING SECTION
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.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
OTC - STOP USE SECTION
Stop using this product after 3 days.
If symptoms persist, stop, and consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
If you are pregnant or breast-feeding consult a health care professional before using this product.
Directions
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.
Other information
Store between 15°-30°C (59°-86°F).
Avoid exposing bottle to excessive heat and direct sunlight.
Do not accept this product if safety seal is broken or missing.
Keep box for information.
Inactive ingredients
Benzalkonium chloride, purified water, sodium bisulfite, sodium chloride, and sodium citrate.
Package Label - Principal Display Panel
0.5 FL. OZ NDC: 48462-001-01
Drug Facts Panel on Outer Box
0.5 FL. OZ NDC: 48462-001-02
Name of Product Outer box
0.5 FL. OZ NDC: 48462-001-02
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e18001c8-33ae-5f66-9cdc-a39724bd4573 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 48462-001-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-fc9d-0266-e053-dadaa90a7c1a | Naphazoline hydrochloride 0.05% v/v |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48462-001-01 | NAFASOLINA | 13310 mg in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 13310 | 1 | |
| 48462-001-02 | NAFASOLINA | 13310 in 1 CARTON | SOLUTION/ DROPS | 13310 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- NAFASOLINA
- NAPHAZOLINE HYDROCHLORIDE
- SODIUM CHLORIDE
- BENZALKONIUM CHLORIDE
- SODIUM BISULFITE
- WATER
- NAPHAZOLINE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48462-001 | 48462-001-01, 48462-001-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| SODIUM BISULFITE | TZX5469Z6I | IACT |
| WATER | 059QF0KO0R | IACT |
| NAPHAZOLINE HYDROCHLORIDE | MZ1131787D | ACTIB |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| baf40d48-157a-8c07-e053-2a95a90a2c28 | baf40abf-9623-e80f-e053-2a95a90ae9cd | 2021-02-10 | Warnings | baf40d48-157a-8c07-e053-2a95a90a2c28 baf40abf-9623-e80f-e053-2a95a90ae9cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.