NAFASOLINA- naphazoline hydrochloride solution/ drops 
DUY DRUGS, INC

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.

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Naphazoline hydrochloride 0.05% v/v

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.

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.

Stop using this product after 3 days.

If symptoms persist, stop, and consult a doctor.

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

48462-001-01 BOTTLE

Drug Facts Panel on Outer Box

0.5 FL. OZ NDC: 48462-001-02

48462-001-02 DRUG FACTS OUTER BOX

Name of Product Outer box

0.5 FL. OZ NDC: 48462-001-02

48462-001-02 NAME OF PRODUCT OUTER

NAFASOLINA 
naphazoline hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48462-001
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.376 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48462-001-0213310 in 1 CARTON02/15/2021
1NDC:48462-001-0113310 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/15/2021
Labeler - DUY DRUGS, INC (162053206)
Registrant - DUY DRUGS, INC (162053206)
Establishment
NameAddressID/FEIBusiness Operations
DEXTRUM LABORATORIES INC.007392322manufacture(48462-001)
Establishment
NameAddressID/FEIBusiness Operations
DUY DRUGS, INC162053206label(48462-001)

Revised: 2/2021
Document Id: baf40d48-157a-8c07-e053-2a95a90a2c28
Set id: baf40abf-9623-e80f-e053-2a95a90ae9cd
Version: 1
Effective Time: 20210210
 
DUY DRUGS, INC