Label: NAFASOLINA- naphazoline hydrochloride solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 48462-001-01, 48462-001-02 - Packager: DUY DRUGS, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 10, 2021
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- Active Ingredient(s)
- Purpose
- Use
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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.
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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.
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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- Name of Product Outer box
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INGREDIENTS AND APPEARANCE
NAFASOLINA
naphazoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48462-001 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE 0.376 mg in 100 mg Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 mg in 100 mg BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 1 mg in 100 mg SODIUM BISULFITE (UNII: TZX5469Z6I) 1 mg in 100 mg WATER (UNII: 059QF0KO0R) 95.624 mg in 100 mg SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg in 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48462-001-02 13310 in 1 CARTON 02/15/2021 1 NDC:48462-001-01 13310 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/15/2021 Labeler - DUY DRUGS, INC (162053206) Registrant - DUY DRUGS, INC (162053206) Establishment Name Address ID/FEI Business Operations DEXTRUM LABORATORIES INC. 007392322 manufacture(48462-001) Establishment Name Address ID/FEI Business Operations DUY DRUGS, INC 162053206 label(48462-001)
