Label: DG HEALTH CHILDRENS MUCUS RELIEF- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 7, 2019

If you are a consumer or patient please visit this version.

  • 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?

    1-888-309-9030

  • Package/Label Principal Display Panel

    Compare to active ingredients of Children’s Mucinex® Multi-Symptom Cold

    For Ages 4 to 12 Years

    Children’s

    Mucus Relief

    Multi-Symptom Cold

    Guaifenesin 100 mg – Expectorant

    Dextromethorphan HBr 5 mg – Cough Suppressant

    Phenylephrine HCl 2.5 mg – Nasal Decongestant

    Relieves stuffy nose, chest congestion, cough, breaks up mucus

    Mixed Berry Flavor

    4 FL OZ (118 mL)

    DG Health Chioldren's Mucus Relief image 1
    DG Health Children's Mucus Relief image 2
  • INGREDIENTS AND APPEARANCE
    DG HEALTH CHILDRENS MUCUS RELIEF 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-839
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    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:55910-839-261 in 1 CARTON05/06/2015
    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 finalpart34105/06/2015
    Labeler - Dolgencorp Inc (068331990)