Label: CHILDRENS PLUS MULTI SYMPTOM COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension

  • NDC Code(s): 41520-704-04
  • Packager: Care One (American Sales Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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

  • Active ingredients (in each 5 mL)

    Acetaminophen 160 mg

    Chlorpheniramine maleate 1 mg

    Dextromethorphan HBr 5 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Pain reliever/fever reducer

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occurif your child takes:

    • more than 5 doses (10 mL) 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

    • 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.
    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

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

    Ask a doctor or pharmacist before use if your child is taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

    When using this product

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

    Stop use and ask a doctor if

    • new symptoms occur
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • pain, nasal congestion or cough gets worse or lasts for more than 5 days
    • nervousness, dizziness or sleeplessness occurs
    • 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: 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 for adultsas well as children even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • mL=milliliter
    • shake well before using
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • do not give more than 5 doses in any 24-hours period
    • if needed, repeat dose every 4 hours while symptoms last
    • find the right dose on chart below. If possible, use weight to dose, otherwise, use age.
    Weight (lb)Age (yr)Dose (mL)
     48-956-1110 mL
     36-47 4-5 do not use unless directed by a doctor
    under 36under 4do not use
  • Other Information

    • store between 20-25ºC (68-77ºF)
    • do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

  • Questions or comments?

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

  • Principal Display Panel

    For Ages 6-11 Years 

    Children's Multi-Symptom Cold

    Pain Relief / Fever Reducer - ACETAMINOPHEN, 160 mg 

    Antihistamine - Chlorpheniramine Maleate, 1 mg

    Cough Suppressant - Dextromethorphan HBr, 5 mg

    Nasal Decongestant - Phenylephrine HCI, 2.5 mg

    FOR RELIEF OF:

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

    Oral Suspension

    Dosage Cup Provided

    Grape Flavored

    FL OZ (mL)

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DISTRIBUTED BY:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

  • Package Label

    Acetaminophen 160 mg, chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, Phenylephrine HCI 2.5 mg

    CAREONE Childrens Multi-Symptom Cold Grape Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PLUS MULTI SYMPTOM COLD 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-704
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-704-041 in 1 BOX10/31/2015
    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 DrugM01210/31/2015
    Labeler - Care One (American Sales Company) (809183973)