Ephrine Nose Drops: Package Insert and Label Information

EPHRINE NOSE DROPS- phenylephrine hydrochloride solution/ drops
Walgreens

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.

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

Other information

•store at 20-25°C (68-77°F)
•Protect from light. Store in outer carton until contents used.

Inactive Ingredients

anhydrous citric acid, benzalkonium chloride solution, purified water, sodium chloride, sodium citrate

Questions or comments ?

1-800-925-4733

Principal Display Panel (carton)

Compare to Neo-Synephrine® active ingredient

Ephrine Nose Drops

PHENYLEPHRINE HCl 1.0% / NASAL DECONGESTANT

EXTRA STRENGTH

Fast relief

1 FL OZ (30 mL)

carton
(click image for full-size original)

Principal Display Panel (Label)

bottle
(click image for full-size original)

EPHRINE NOSE DROPS
phenylephrine hydrochloride solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2023
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE
WATER
BENZALKONIUM CHLORIDE
ANHYDROUS CITRIC ACID
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-2023-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0363-2023-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/15/2021
Labeler — Walgreens (008965063)

Revised: 07/2021 Walgreens

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