Label: CHILDRENS UNIPHED NASAL DECONGESTANT- pseudoephedrine 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 April 30, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL*1)

    Pseudoephedrine HCl, USP 15 mg

    1
    * 5 mL = one teaspoonful
  • Purpose

    Nasal Decongestant

  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis
    • temporarily relieves sinus congestion and pressure
    • promotes nasal and/or sinus drainage
  • Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    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

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepness
    • symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    • take every 4 to 6 hours
    • do not take more than 4 doses in 24 hours
    children under 2 years of ageask a doctor
    children 2 to under 6 years of ageone (1) teaspoonful
    children 6 to under 12 years of agetwo (2) teaspoonfuls
    adults and children 12 years of age and overfour (4) teaspoonfuls
  • Other information

    • TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
    • protect from light
    • each teaspoon (5 mL) contains: sodium 4 mg
    • Store at room temperature 15º - 30ºC (59º - 86ºF)
  • Inactive ingredients

    citric acid, edetate disodium, FD&C Red #40, FD&C blue #1, flavor, glycerin, poloxamer, polyethylene glycol, povidone K-90, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, and water

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CHILDRENS UNIPHED   NASAL DECONGESTANT
    pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-422
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine hydrochloride15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    povidone K90 (UNII: RDH86HJV5Z)  
    water (UNII: 059QF0KO0R)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-422-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-422)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!