FDA Label for Little Remedies Decongestant Nasal Drops

View Indications, Usage & Precautions

Little Remedies Decongestant Nasal Drops Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products 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.

Little Decongestant Drops



Drug Facts


Active Ingredient



Phenylephrine Hydrochloride 0.125%


Purpose



Nasal decongestant


Uses



  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
  • 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 The Child Has



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

When Using This Product



  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • the use of this dispenser by more than one person may spread infection
  • do not use more than 3 days. Ues only as directed. Frequest or prolonged use may cause nasal congestion to revcur or worsen.

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



(nasal use only)

  • Children 2 to under 6 years (with adult supervision): 2 to 3 drops in each nostril, not more often than every 4 hours. Use only recommended amount. 
  • Children under 2 years of age: Consult a doctor

Other Information



  • Do not use if solution is brown or contains a precipitate.
  • Protect from light.
  • Store at 20-25°C (68-77°F).
  • See bottle or box for lot number and expiration date.

Inactive Ingredients



benzalkonium chloride, glycerin, polyethylene glycol, potassium phosphate monobasic, purified water, sodium edta, sodium phosphate dibasic


Questions?



1-800-754-8853 Mon. – Fri. 8 am to 8 pm EST. www.LittleRemedies.com


Principal Display Panel



Little Remedies® 

DECONGESTANT NOSE DROPS
Phenylephrine HCl / Nasal Decongestant

0.5 FL OZ (15 mL)


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