Label: COUGH AND COLD- chlorpheniramine maleate and dextromethorphan hydrobromide liquid 

  • Label RSS
  • NDC Code(s): 45014-151-04
  • Packager: Accudial Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/09

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

  • SPL UNCLASSIFIED SECTION

    COUGH & COLD LONG-ACTING

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients
    (in each 5 mL tsp)
    Purposes
    Chlorpheniramine maleate, USP 1 mg Antihistamine
    Dextromethorphan HBr, USP 7.5 mg Cough suppressant
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  • 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
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  • 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.

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  • 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
    age dose
    under 6 years do not use
    6 to under 12 years 1-2 tsp. (5-10 mL) every 6 hours
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  • Other information

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

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

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  • Questions?

    877-434-2036

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  • 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
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  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD 
    chlorpheniramine maleate and dextromethorphan hydrobromide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45014-151
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 1 mg  in 5 mL
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Fruit  
    Citric Acid Monohydrate  
    FD&C RED NO. 40  
    Glycerin  
    Water  
    Sodium Benzoate  
    Sodium Citrate  
    Sorbitol  
    Sucralose  
    Product Characteristics
    Color RED (Reddish-Pink) , PINK Score     
    Shape Size
    Flavor FRUIT PUNCH Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45014-151-04 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 11/25/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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