Ephrine Nose Drops Solution/ Drops
FDA Label NDC 0363-2023

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Ephrine Nose Drops (NDC 0363-2023). 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 active ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments ?

→ Principal Display Panel (carton)

→ Principal Display Panel (label)

Active Ingredient

Phenylephrine hydrochloride 1.0%

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to:
•common cold
•hay fever
•upper respiratory allergies
•temporarily relieves sinus congestion and pressure
•shrinks swollen membranes so you can breathe more freely
•temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

•heart disease
•high blood pressure
•thyroid disease
•diabetes
•trouble urinating due to an enlarged prostate gland

When using this product

•do not use more than directed
•do not use 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 an increase in nasal discharge may occur
•use of this container by more than one person may spread infection

Stop use and ask a doctor if

symptoms persist

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•use only as directed
•adults and children 12 years of age and older: 2 or 3 drops in each nostril not more often than every 4 hours
•children under 12 years of age: ask a doctor