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  5. Label Information: Theraflu Severe Congestion Relief Cooling Nasal Mist

FDA Label for Theraflu Severe Congestion Relief Cooling Nasal Mist

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. ADDITIONAL INFORMATION
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Theraflu Severe Congestion Relief Cooling Nasal Mist Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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



Oxymetazoline HCl 0.05%


Purpose



Nasal decongestant


Uses



  • •temporarily relieves nasal decongestion due to:
    • ocommon cold
    • ohay fever or other upper respiratory allergies (allergic rhinitis)
    • •temporarily relieves stuffy nose
    • •helps clear nasal passages; shrinks swollen membranes
    • •temporarily restores freer breathing through the nose
    • •helps decongest sinus openings and passages; 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 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. If symptoms persist, consult a doctor.
  • •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

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.


Directions



  • •do not use more than directed
  • •adults and children 6 years to under 12 years of age (with adult supervision): 2 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: consult a doctor

    • To Use: Shake well before use. To remove the cap, press grooves on each side and turn to lift cap. Before using the first time, prime the sprayer by pressing the button several times. To spray, insert sprayer tip into nostril, firmly press the button with thumb and sniff deeply. Stay upright while spraying. Wipe sprayer tip clean and secure cap after use.


Other Information



  • •do not store above 25°C (77°F)

Inactive Ingredients



benzalkonium chloride solution, edetate disodium, eucalyptol, menthol, polyoxyl 40 hydrogenated castor oil, purified water, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, sorbitol


Questions?



1-855-328-5259


Additional Information



READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

Breathe Better at the Push of a Button

1. Find grooves on each side of cap

2. Press grooves and turn to lift cap

3. Press firmly with thumb

Do not use if red unlock icon is seen on either end of the carton before first opening or if the red unlock icon is absent after opening.

*vs. the leading nasal mist


Package/Label Principal Display Panel



NEW

THERAFLU

SEVERE

CONGESTION RELIEF

COOLING

NASAL MIST

Oxymetazoline HCl –

Nasal Decongestant

12 HR RELIEF

UNBLOCKS IN SECONDS

Comfortable to use

  • •One-thumb push of a button
  • •Shorter nozzle*
  • •Ultra fine mist

    • 0.34 FL OZ (10 mL)


* Please review the disclaimer below.