Label: ALLERGY AND STUFFY NOSE- chlorpheniramine maleate and 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 November 11, 2009

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    ALLERGY & STUFFY NOSE

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL, 1 teaspoonful)    		Purposes
    Chlorpheniramine maleate 1 mgAntihistamine
    Phenylephrine HCl 2.5 mgNasal decongestant
  • Uses

    • temporarily relieves
      • itchy, watery eyes
      • runny nose
      • itchy nose or throat
      • sneezing
      • nasal and sinus congestion as may occur with a cold
  • Warnings

    Do not use

    • in a child under 4 years of age
    • in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    • for the purpose of making your child sleepy

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as asthma or chronic bronchitis

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not improve within 7 days or occur with a fever. These could be signs of a serious condition.

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

  • Directions

    • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
    • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age.
    • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device.
    AgeDose
    children under 4 years of agedo not use
    children 4 to under 6 years of agedo not use unless directed by a doctor
    children 6 to under 12 years of age1-2 tsp. (5-10 mL)
  • Other information

    • each teaspoonful contains: sodium 3 mg
    • store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

  • Questions?

    877-434-2036

  • PRINCIPAL DISPLAY PANEL - 118 mL Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    Allergy
    & Stuffy Nose

    ACCURATE DOSING
    BY WEIGHT

    Chlorpheniramine maleate
    (Antihistamine)

    Phenylephrine HCl
    (Nasal Decongestant)

    Itchy, Watery Eyes
    Runny Nose
    Stuffy Nose
    Sneezing

    For Ages 6 to under 12

    Compares to
    Children's Triaminic®
    Cold & Allergy.

    ORANGE
    FLAVOR

    4 FL. OZ.
    (118 mL)
    NDC 45014-141-04

    Principal Display Panel - 118 mL Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY AND STUFFY NOSE 
    chlorpheniramine maleate and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate1 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Orange (UNII: 5EVU04N5QU)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-141-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/11/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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!