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

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

Drug Label Information

Updated May 10, 2024

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  • 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)
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