Label: COUGH AND COLD- chlorpheniramine maleate and dextromethorphan hydrobromide 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

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  • SPL UNCLASSIFIED SECTION

    COUGH & COLD LONG-ACTING

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL tsp)    		Purposes
    Chlorpheniramine maleate, USP 1 mgAntihistamine
    Dextromethorphan HBr, USP 7.5 mgCough suppressant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • 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

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or 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
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • 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 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
    under 6 yearsdo not use
    6 to under 12 years1-2 tsp. (5-10 mL) every 6 hours
  • Other information

    • each teaspoon contains: sodium 2 mg
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

  • Questions?

    877-434-2036

  • PRINCIPAL DISPLAY PANEL - 118 mL Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    Cough & Cold
    Long-Acting

    ACCURATE DOSING
    BY WEIGHT

    Chlorpheniramine Maleate
    (Antihistamine)

    Dextromethorphan HBr
    (Cough Suppressant)

    RELIEVES
    Cough: Up to 8 Hours
    Runny Nose

    For Ages 6 to under 12

    Compares to Children's
    Robitussin® Cough &
    Cold Long-Acting.

    FRUIT
    PUNCH
    FLAVOR

    4 FL. OZ.
    (118 mL)
    NDC 45014-151-04

    Principal Display Panel - 118 mL Carton
  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD 
    chlorpheniramine maleate and dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-151
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate1 mg  in 5 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Fruit (UNII: C2AIY4ERZC)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Sorbitol (UNII: 506T60A25R)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED (Reddish-Pink) , PINKScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-151-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/25/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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