Label: CVS CHILDRENS COLD PLUS COUGH PLUS RUNNY NOSE- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 22, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)Purposes

    Acetaminophen 160 mg

    Pain reliever/fever reducer

    Chlorpheniramine maleate 1 mg

    Antihistamine

    Dextromethorphan HBr 5 mg

    Cough suppressant

  • Uses

    • temporarily relieves the following cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • sneezing and runny nose
      • cough
    • temporarily reduces fever
  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    Allergy alert:acetaminophen may cause severe skin reactions.

    Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • to make a child sleepy
    • 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.
    • if your child has ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if your child has

    • liver disease
    • a breathing problem such as chronic bronchitis
    • glaucoma
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if your child is

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dose (see overdose warning)
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see overdose warning)
    • shake well before using
    • mL = milliliter
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • remove the child protective cap and squeeze your child's dose into the dosing cup
    • repeat dose every 4 hours, while symptoms last
    • do not give more than 5 times in 24 hours
    Weight (lb)Age (yr)Dose (mL)

    under 36

    under 4 years

    do not use

    36-47

    4 to 5 years

    do not use unless directed by a doctor

    48-95

    6 to 11 years

    10 mL

    Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL contains:sodium 3 mg
    • store at room temperature

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC 69842-792-04

    CVS Health ®

    Compare to the active ingredients in Children’s Tylenol ®Cold + Cough + Runny Nose*

    Suspension Liquid

    Children's Cough &
    Runny Nose

    ACETAMINOPHEN,

    Pain Reliever-Fever Reducer

    CHLORPHENIRAMINE MALEATE,

    Antihistamine
    DEXTROMETHORPHAN HBr

    Cough Suppressant

    Relieves:

    • Fever & Sore Throat
    • Sneezing & Runny Nose
    • Cough

    Dosing cup included

    Grape Flavor

    Ages 6-11

    4 FL OZ (120 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    Package contains One Bottle

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2020 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-12431

    CVS ®Quality

    Money Back Guarantee

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol ®Cold + Cough + Runny Nose.

    CVS Health Children's Cough & Runny Nose
  • INGREDIENTS AND APPEARANCE
    CVS CHILDRENS   COLD PLUS COUGH PLUS RUNNY NOSE
    acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-792
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-792-041 in 1 CARTON03/30/2020
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/30/2020
    Labeler - CVS (062312574)