Label: CHILDRENS COUGH AND COLD CF- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • 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 June 16, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)
    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 100 mg
    Phenylephrine HCI, USP 5 mg

  • PURPOSE

    Purpose
    Dextromethorphan HBr, USP .......... Cough suppressant
    Guaifenesin, USP ......................................Expectorant
    Phenylephrine HCI, USP ................. Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    • helps loosen phlegm (mucus) and thin bronchial
      secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring
      with a cold: • nasal congestion • cough due to minor
      throat and bronchial irritation

  • WARNINGS

    Warnings
    Do not use if you are now taking aprescription
    monoamine oxidase inhibitor (MAOI) (certain drugs for
    depression, psychiatric, or emotional conditions, or
    Parkinson's diseases) or for 2 weeks after stopping the
    MAOI drug. If you do not know if your prescription drug
    contains an MAOI, ask a doctor or pharmacist before
    taking this product.

    Ask a doctor before use if you have
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with
    smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking
    any other oral nasal decongestant or stimulant

    When using this product
    • do not use more than directed

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occurs
    • symptoms do not get better within 7 days or are
      accompanied by fever
    • cough lasts more than 7 days, comes back, or is
      accompanied by fever, rash, or persistent headache.
    These could be signs of a serious condition.

    If pregnant or breast feeding, ask aheaith professional
    before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get
    medical heip or contact a Poison Control Center
    (1-800-222-1222) immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • mL = milliliter

             age                                                                dose                                            
    children under 4 years    do not use
    children 4 to under

        6 years

    		5 mL every 4 hours
    children 6 to under

       12 years

    		10 mL every 4 hours
    adults and children

     12 years and over

    		20 mL every 4 hours

  • OTHER SAFETY INFORMATION

    Other information
    • each 10 mL contains: sodium 6 mg
    • store at room temperature. Do not refrigerate.

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid,

    FD&C Blue # 1, FD&C Red # 40, flavor, glycerin,

    propylene glycol, purified water, sodium benzoate,

    sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments? Call weekdays from
    9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Product Labeling

    CVS
    Health®

    Compare to the active
    ingredients in Children's
    Robitussin® Cough
    & Cold CF*

    Non-drowsy

    NDC 76281-325-24

    Children's
    Cough
    & Cold CF

    Ages 4+

    Grape Flavor

    4 FL OZ (118 mL)

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    ©2021 CVS/pharmacy

    CVS.COM 1-800-SHOP-CVS                     BX-128 Rev01

    *This product is not manufactured or distributed by

    Pfizer, distributor of Children's Robitussin® Cough

    & Cold CF.

    325-24 Crtn

    325-24 Btl

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COUGH AND COLD CF 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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
    ColorpurpleScore    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-325-241 in 1 CARTON06/08/2021
    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 finalpart34106/08/2021
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-325)
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