SUNMARK COLD AND COUGH DM CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MCKESSON]

SUNMARK COLD AND COUGH DM CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [MCKESSON]
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NDC 49348-775-34
Set ID 46723e5a-bf0e-41d3-bd64-448ae44a924c
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 10 mL)

    Brompheniramine maleate, USP 2 mg

    Dextromethorphan HBr, USP 10 mg

    Phenylephrine HCl, USP 5 mg

  • Purposes

    Antihistamine

    Cough suppressant

    Nasal 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

    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
    trouble urinating due to an enlarged prostate gland
    glaucoma
    cough that occurs with too much phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are

    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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).

  • 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?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO CHILDREN’S DIMETAPP® COLD & COUGH ACTIVE INGREDIENTS

    for ages 6 & up

    Children’s

    cold & cough DM

    ANTIHISTAMNIE

    Brompheniramine Maleate

    COUGH SUPPRESSANT

    Dextromethorphan HBr

    NASAL DECONGESTANT

    Phenylephrine HCl

    Relieves cold & allergy symptoms

    Alcohol Free

    RED GRAPE FLAVORED

    GLUTEN FREE

    4 FL OZ (118 mL)

    SunMark Children's Cold & Cough DM image
  • INGREDIENTS AND APPEARANCE
    SUNMARK COLD AND COUGH DM  CHILDRENS
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-775
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPURPLE (Clear bluish-red) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-775-341 in 1 CARTON09/11/2006
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/11/2006
    Labeler - Strategic Sourcing Services LLC (116956644)