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  5. Label Information: Dristan 12 Hr

FDA Label for Dristan 12 Hr

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 15 ML BOTTLE CARTON

Dristan 12 Hr Product Label

The following document was submitted to the FDA by the labeler of this product Foundation Consumer Brands. 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.

Other



Drug Facts

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212


Active Ingredient



Oxymetazoline hydrochloride 0.05%


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to a cold, hay fever or other upper respiratory allergies
  • shrinks swollen membranes
  • temporarily restores freer breathing through the nose
  • temporarily relieves sinus congestion and pressure

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
  • 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

Otc - Stop Use



Stop use and ask a doctor if symptoms persist


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistant closure.

Other Information



  • store at 20-25°C (68-77°F)
  • container is filled to proper level for correct spray action
  • retain carton for full labeling

Inactive Ingredients



benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride


Questions Or Comments?



Call 1-888-594-0710 weekdays 9 AM to 5 PM EST


Principal Display Panel - 15 Ml Bottle Carton



Dristan®
12
HOUR
NASAL
SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Fast Acting Relief
Sinus & Nasal
Congestion

Relieves:

* Please review the disclaimer below.