Label: DRKIDS CHILDRENS MULTI SYMPTOM COLD COUGH AND CONGESTION DM- dextromethorphn hbr 5mg, guaifenesin 100mg, phenylephrine hcl 2.5mg solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • Active Ingredients (in each 5 mL)

    Dextromethorphan HBr, 5mg

    Guaifenesin, 100mg

    Phenylephrine HCl, 2.5mg

    Purposes

    Cough suppressant

    Expectorant

    Nasal Decongestant

  • Uses

    ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

    ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help your child get to sleep ■ nasal congestion due to a cold ■ stuffy nose

  • Warnings

    Do not use

    in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor if your child has

    ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with asthma

    Ask a doctor or pharmacist before use if your child is

    taking any other decongestant or stimulant.

    When using this product

    do not exceed recommended dosage (see overdose warning)

    Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleeplessness occur ■ symptoms do not get better within 7 days or occur with fever ■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    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

    ■ this product does not contain directions or complete warnings for adult use

    ■ do not give more than 6 times in 24 hours

    ■ give the recommended number of vials below following the instructions under “Easy to Use” on the side panel.

    ■ empty all liquid in each Single-Use Vial when dosing

    ■ use the chart below to confirm the dose

    Dosing chart

    Age (years)Dose (mL)
    under 4 yearsDo not use
    4 to 5 years1 Single-Use Vial (5mL) every 4 hours. Do not give more than 6 times in 24 hours
    6 to 11 years2 Single-Use Vials (10mL) every 4 hours. Do not give more than 6 times in 24 hours

  • Other information

    ■ each Single -Use vial contains 5mg of sodium

    ■ store at 20-25°C (68-77°F)

    ■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.

  • Inactive ingredients

    citric acid, edetate disodium, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.

  • Questions or Comments?

    941-202-3270 or visit www.DrKids.com

  • Package Label

    Package

  • INGREDIENTS AND APPEARANCE
    DRKIDS CHILDRENS MULTI SYMPTOM COLD COUGH AND CONGESTION DM 
    dextromethorphn hbr 5mg, guaifenesin 100mg, phenylephrine hcl 2.5mg solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-0116-120 in 1 CARTON02/15/2024
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/15/2024
    Labeler - Calmco (079308308)
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