MedPath

SERYNTH FAST RELIEF NASAL

84010-117

Approved
Approval ID

35c90ed6-8b07-9507-e063-6394a90a6799

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Naphazoline HCL 0.05% FAST RELIEF NASAL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-117
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Naphazoline HCL 0.05% FAST RELIEF NASAL
Product Specifications
Route of AdministrationNASAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (6)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NAPHAZOLINE HCLActive
Quantity: 0.05 g in 100 mL
Code: MZ1131787D
Classification: ACTIB
BORNEOLInactive
Code: M89NIB437X
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Use

temporarily relieves

·nasal congestion due to a cold, hay fever, or other upper respiratory allergies

·sinus congestion and pressure

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active Ingredient

Naphazoline HCL 0.05%.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Nasal Decongestant

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

Do not use

·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

·temporary discomfort such as burning, stinging,sneezing, or increased nasaldischarge may occur
·use of this container by more than one person may spread infection
do not use children under 2 years.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

Ask a doctor before use if you have

·heart disease

·high blood pressure
·thyroid disease
·diabetes
·trouble urinating due to enlarged prostate gland

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/23/2025

When Using

·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

·temporary discomfort such as burning, stinging,sneezing, or increased nasaldischarge may occur
·use of this container by more than one person may spread infection

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/23/2025

Stop Use

Stop use and ask a doctor if symptoms persist.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/23/2025

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.

children 2 to under 6 years.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

Keep Out Of Reach Of Children

If swallowed,get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Directions

adults&children 6 years &older(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 24 hours

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/23/2025

Other information

do not exceed 25°C.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

borneol,Camphor,glycerin,menthol,propylene glycol,etc.

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