Label: COUGH COLD AND SORE THROAT CHILDRENS- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

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

Drug Label Information

Updated May 8, 2024

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

  • Active ingredients (in each 10 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • cough due to minor throat and bronchial irritation
      • the intensity of coughing
      • the impulse to cough to help your child get to sleep
      • nasal congestion
      • stuffy nose
      • sore throat
      • minor aches and pains
      • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive 
  • 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 monprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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 is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if your child has

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

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

    When using this product,

    do not use more than directed (see Overdose warning).

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion or cough gets worse or lasts more than 5 days
    • redness or swelling is present
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • cough comes back, or occurs with a rash or headache that lasts.

    These could be signs of a serious condition.

    Keep out of reach of children

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical 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)
    • do not give more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 days unless directed by a doctor
    • keep dosing cup with product
    • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • dose as follows, or as directed by a doctor
    • mL=milliliter
    • children 6 to under 12 years of age: 10 mL in dosing cup provided
    • children under 6 years of age: do not use 
  • Other information

    • each 10 mL contains: sodium 6 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredients in Children's Mucinex® Cold, Cough & Sore Throat††

    Children's

    Cold, Cough & Sore Throat

    ACETAMINOPHEN 325 mg /

    PAIN RELIEVER / FEVER REDUCER

    DEXTROMETHORPHAN HBr 10 mg /

    COUGH SUPPRESSANT

    GUAIFENESIN 200 mg / EXPECTORANT

    PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

    • Relief from cough, sore throat, stuffy nose & chest congestion
    • Breaks up mucus

    AGES 6 - 11 YEARS

    FL OZ (mL)

    Berry flavor

    ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cold, Cough & Sore Throat.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Package Label

    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg

    WALGREENS Children's Cold, Cough, and Sore Throat Berry Flavor

  • INGREDIENTS AND APPEARANCE
    COUGH COLD AND SORE THROAT  CHILDRENS
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    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
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4050-041 in 1 BOX10/31/2014
    1118 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 DrugM01210/31/2014
    Labeler - Walgreens (008965063)