Label: LITTLE REMEDIES DECONGESTANT NASAL DROPS- phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 29, 2020

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  • SPL UNCLASSIFIED SECTION

    LITTLE REMEDIES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid
    ----------

    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
  • Warnings

    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.

    Stop use and ask a doctor if

    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 20-25ºC (68-77ºF).
    • 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)

    Little Remedies® DECONGESTANT NOSE DROPS Phenylephrine HCl / Nasal Decongestant 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    LITTLE REMEDIES DECONGESTANT NASAL DROPS 
    phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-403
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    Product Characteristics
    ColorWHITE (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-403-151 in 1 CARTON01/01/2017
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/2017
    Labeler - Medtech Products Inc. (122715688)
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