Label: TOPCARE CHILDRENS MUCUS RELIEF MULTI SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

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

Drug Label Information

Updated November 11, 2024

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  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

    Phenylephrine HCl 2.5 mg

  • 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 before use if the 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

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    •
    your child gets nervous, dizzy or sleepless
    •
    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

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    do not use dosing cup with other products
    •
    dose as follows or as directed by a doctor
    •
    mL = milliliter

    Age

    Dose

    children 6 years to under 12 years

    10 mL every 4 hours

    children 4 years to under 6 years

    5 mL every 4 hours

    children under 4 years

    do not use

    Other information

    •
    each 5 mL contains: sodium 3 mg
    •
    do not use if printed neckband is broken or missing
    •
    store at 20-25°C (68-77°F)
    •
    do not refrigerate
    •
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

    Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    COMPARE TO CHILDREN’S MUCINEX® MULTI-SYMPTOM COLD ACTIVE INGREDIENTS

    children’s

    Multi-Symptom

    Cold

    Mucus Relief

    OUR PHARMACISTS RECOMMEND

    COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

    EXPECTORANT - GUAIFENESIN

    NASAL DECONGESTANT – PHENYLEPHRINE HCl

    Controls Cough

    Relieves Chest Congestion

    Breaks Up Mucus

    Relieves Stuffy Nose

    ALCOHOL FREE

    Ages 4 to 12 Years

    VERY BERRY FLAVOR

    4 FL OZ (118mL)

    childrens mucus relief image
  • INGREDIENTS AND APPEARANCE
    TOPCARE CHILDRENS MUCUS RELIEF MULTI SYMPTOM COLD 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-839
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorRED (clear) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-839-261 in 1 CARTON08/08/201409/30/2025
    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 DrugM01208/08/201409/30/2025
    Labeler - Topco Associates LLC (006935977)
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