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healthy accents cough and sore throat (DZA Brands LLC)

Available Formats

Dosage Form Package Information Links
LIQUID 237 mL in 1 BOTTLE (55316-666-34) Label Information

Complete healthy accents cough and sore throat Information

  • Active ingredients (in each 15 mL = 1 tablespoon)

    Acetaminophen 500 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg


  • Purpose

    Pain reliever

    Cough suppressant

    Antihistamine


  • Uses

    • temporarily relieves the following cold/flu symptoms:
    • headache
    • cough
    • runny nose and sneezing
    • sore throat
    • minor aches and pains

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4 doses 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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.
    • to make a child sleepy

    Ask a doctor before use if you have
    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if
    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts.

    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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • Directions

    • do not take more than directed (see Liver warning)

    adults and children 12 years and over

    • take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed
    • do not take more than 8 tablespoons in 24 hours

    children under 12 years

    • do not use this adult product in children under 12 years of age

  • Other information

    • each tablespoon contains: potassium 20 mg and sodium 8 mg
    • store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose


  • Questions or comments?

    1-866-322-2439


  • Principal Display Panel

    Compare to Tylenol® Cough & Sore Throat active ingredients

    nighttime

    cough & sore throat

    pain reliever – cough suppressant – antihistamine

    sore throat, body aches/headache (acetaminophen)

    coughing (dextromethorphan HBr)

    runny nose (doxylamine succinate)

    Cool Ice® instant cooling sensation

    8 FL OZ (237 mL)

    Healthy Accents Cough & Sore Throat 1.jpg
    Healthy Accents Cough & Sore Throat 2.jpg

  • INGREDIENTS AND APPEARANCE
    HEALTHY ACCENTS COUGH AND SORE THROAT  NIGHT TIME
    acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-666
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color BLUE (clear) Score     
    Shape Size
    Flavor MENTHOL Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-666-34 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/24/2008 02/12/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/24/2008 02/12/2018
    Labeler - DZA Brands LLC (090322194)