Label: GOOD SENSE COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

  • Category: HUMAN OTC DRUG LABEL

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 January 12, 2022

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  • 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
    •
    minor aches and pains
    •
    headache
    •
    minor sore throat pain
    •
    runny nose
    •
    itchy nose or throat
    •
    sneezing
    •
    itchy, watery eyes due to hay fever
    •
    cough due to minor throat and bronchial irritation as may occur with a cold
    •
    nasal and sinus congestion
    •
    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

    •
    in a child under 4 years of age
    •
    if your child has ever had an allergic reaction to this product or any of its ingredients
    •
    with any other drug containing acetaminophen (prescription or nonprescription). 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.
    •
    to make a child sleepy

    Ask a doctor before use if the child has

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

    Ask a doctor or pharmacist before use if the child is

     
    taking
    •
    the blood thinning drug warfarin
    •
    sedatives or tranquilizers

    When using this product

    •
    do not exceed recommended dosage
    •
    marked drowsiness may occur
    •
    sedatives and tranquilizers may increase drowsiness
    •
    excitability may occur, especially in children

    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
    •
    fever gets worse or lasts more than 3 days
    •
    redness or swelling is present
    •
    new symptoms occur
    •
    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). Prompt 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)
    •
    shake well before using
    •
    remove the child protective cap and squeeze your child’s dose into the dosing cup
    •
    may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
    •
    use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.

    Age

    Dose

    children under 4 years of age

    do not use

    children 4 to under 6 years of age

    do not use unless directed by a doctor

    children 6 to under 12 years of age

    10 mL
  • Other information

    •
    each 5 mL contains: sodium 3 mg
    •
    contains no aspirin
    •
    store between 20-25°C (68-77°F). Protect from light.
    •
    close cap tightly
  • Inactive ingredients

    anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    GOODSENSE®

    Ages 6 to 11 Years

    Children’s Triacting Suspension Multi-Symptom Cold Plus

    Fever Reducer/Pain Reliever (Acetaminophen)

    Cough Suppressant (Dextromethorphan HBr)

    Nasal Decongestant (Phenylephrine HCl)

    Antihistamine (Chlorpheniramine Maleate)

    • Fever • Cough

    • Runny & Stuffy Nose

    • Aches & Pains

    • Sore Throat

    Grape Flavor

    Compare to active ingredients of Children’s Triaminic® Multi-Symptom Fever & Cold

    4 FL OZ (118 mL)

    903-c2-multi-symptom-cold-plus
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE COLD 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0903
    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
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    Product Characteristics
    ColorPURPLE (opaque) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0903-261 in 1 CARTON12/22/2010
    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 finalpart34112/22/2010
    Labeler - L. Perrigo Company (006013346)
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