Label: RUNNY NOSE AND COUGH- brompheniramine maleate, dextromethorphan hydrobromide 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 4, 2009

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  • SPL UNCLASSIFIED SECTION

    RUNNY NOSE & COUGH

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL tsp)    		Purposes
    Brompheniramine maleate, USP .5 mgAntihistamine
    Dextromethorphan HBr, USP 5 mgCough suppressant
    Phenylephrine HCl, USP 1.25 mgNasal decongestant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    • to sedate a child or to make a child sleepy
    • 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 taking this product.

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

    When using this product

    • do not use more than directed
    • may cause marked drowsiness
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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

    • do not take more than 4 doses in any 24-hour period
    • 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 6 to under 12 years1½-3 tsp. (7.5-15 mL) every 6 hours
    children under 6 yearsdo not use
  • Other information

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

    artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.

  • Questions?

    877-434-2036

  • PRINCIPAL DISPLAY PANEL - 118 mL Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    ACCURATE DOSING
    BY WEIGHT

    Nasal Decongestant
    Antihistamine
    Cough Suppressant

    RELIEVES
    Nasal Congestion
    Runny Nose
    Itchy, Watery Eyes
    Coughing, Sneezing

    For Ages 6 to under 12

    Alcohol Free
    Compares to the
    active ingredients in
    Children's Dimetapp®
    Cold & Cough.

    GRAPE
    FLAVOR

    4 FL. OZ.
    (118 mL)
    NDC 45014-153-04

    Runny Nose & Cough

    Principal Display Panel - 118 mL Carton
  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    RUNNY NOSE AND COUGH 
    brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-153
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate0.5 mg  in 5 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride1.25 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Grape (UNII: 6X543N684K)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-153-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/04/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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