Label: CONGESTION AND COUGH CHILDRENS- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

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

Drug Label Information

Updated May 5, 2023

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

View All Sections
  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg
    Guaifenesin 100 mg
    Phenylephrine HCl 2.5 mg

  • Purpose

    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
      • stuffy nose
      • nasal congestion due to a cold
      • the intensity of coughing
      • the impulse to cough to help the child get to sleep
  • 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

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

    When using this product

    do not exceed recommended dosage.

    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 persists more than 7 days, tends to recur, or is accompanied by a 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.

  • Directions

    • do not take more than directed
    • do not take more than 6 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • dose as follows or as directed by a doctor
    AgeDose
    children 6 to under 12 years10 mL every 4 hours
    children 4 to under 6 years5 mL every 4 hours
    children under 4 yearsdo not use
  • Other information

    • each 5 mL contains: sodium 3 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    ♥CVS
    Health®

    Children's
    Cough &
    Congestion 

    DEXTROMETHORPHAN HBr
    Cough suppressant
    GUAIFENESIN
    Expectorant
    PHENYLEPHRINE HCl
    Nasal decongestant
    Oral Solution

    Relieves:
    • Chest congestion
    • Stuffy nose
    • Cough
    Breaks up mucus

    No added alcohol
    Free of high fructose corn
    syrup, sugar, aspirin
    & ibuprofen

    For Ages 4
    to 11 Years

    Berry Flavor
    Dosage cup included
    Actual Bottle Size on Side Panel

    6.8 FL OZ (201 mL)

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895
    © 2023 CVS/pharmacy
    CVS.com®
    1-800-SHOP CVS
    V-19849

    100% money back
    guaranteed.
    CVS.com/returnpolicy

    50844   REV0223B05688

    CVS 44-056

    CVS 44-056

  • INGREDIENTS AND APPEARANCE
    CONGESTION AND COUGH  CHILDRENS
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-756
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-756-881 in 1 CARTON07/01/2018
    1201 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2018
    Labeler - CVS PHARMACY (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(69842-756) , pack(69842-756)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!