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healthy accents cold and allergy (DZA Brands LLC)

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Dosage Form Package Information Links
LIQUID 1 BOTTLE in 1 CARTON (55316-906-26) > 118 mL in 1 BOTTLE Label Information

Complete healthy accents cold and allergy Information

  • Active ingredients (in each 10 mL)

    Brompheniramine maleate, USP 2 mg

    Phenylephrine HCl, USP 5 mg


  • Purposes

    Antihistamine

    Nasal decongestant


  • Uses

    • temporarily relieves 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
    • 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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • 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 sedatives or tranquilizers

    When using this product
    • do not use more than directed
    • drowsiness may occur
    • 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

    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).


  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosage cup provided
    • keep dosage cup with product
    • mL = milliliter

    age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    children under 6 years

    do not use


  • Other information

    • each 10 mL contains: sodium 4 mg
    • store at 20-25°C (68-77°F)

  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution


  • Questions or comments?

    1-866-322-2439


  • Principal Display Panel

    children’s

    cold & allergy

    antihistamine

    (brompheniramine maleate)

    nasal decongestant

    (phenylephrine HCl)

    for ages 6 yrs. & over

    Compare to Children’s Dimetapp® Cold & Allergy active ingredients

    NO GLUTEN

    grape flavor

    4 fl oz (118mL)

    alcohol free

    Healthy Accents Children's Cold & Allergy

  • INGREDIENTS AND APPEARANCE
    HEALTHY ACCENTS COLD AND ALLERGY  CHILDRENS
    phenylephrine hcl, brompheniramine maleate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-906
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 10 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color PURPLE (clear bluish-red) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-906-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/01/2008
    Labeler - DZA Brands LLC (090322194)