FDA Label for Equaline Fast Acting
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING
- PRINCIPAL DISPLAY
Equaline Fast Acting Product Label
The following document was submitted to the FDA by the labeler of this product Supervalu Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Phenylephrine hydrochloride 1%
Purpose
Nasal decongestant
Uses
for the temporary relief of nasal congestion due to:
• common cold• hay fever• upper respiratory allergies
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 exceed recommended dosage
• do not use for more than 3 days. Use only as directed
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
• the use of this container by more than one person may spread infection
• frequent or prolonged use may cause nasal congestion to recur or worsen
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
• adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more than every 4 hours• children under 12 years of age: ask a doctor• Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
Other Information
• store between 20°-25°C (68°-77°F)• container is filled to proper level for best spray action
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate
Questions
1-877-932-7948
Important: Keep This Carton For Future Reference On Full Labeling
DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING
Distributed By: Supervalu Inc.
Eden Prairie, MN 55344
This product is not manufactured or distributed by Novartis Consumer Health Inc., the owner of the registered trademark 4-Way Fast Acting Nasal Spray.
Principal Display
NDC 41163-728-01
Equaline
Fast Acting
Nasal Spray
Phenylephrine hydrochloride 1%
(nasal decongestant)
fast acting relief of
• nasal congestion• sinus congestion• sinus pressure• swollen nasal passages
1 FL OZ (30mL)
* Please review the disclaimer below.