TOPCARE COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [TOPCO ASSOCIATES LLC]

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  • TOPCARE COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [TOPCO ASSOCIATES LLC]

TOPCARE COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [TOPCO ASSOCIATES LLC]
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NDC 36800-903-26
Set ID 258e679c-4862-4ad8-a62f-bb5da2eaa41a
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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
    •
    nasal and sinus congestion
    •
    cough due to minor throat and bronchial irritation as may occur with a cold
    •
    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 your 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 your child is taking

    •
    sedatives or tranquilizers
    •
    blood thinning drug warfarin

    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 at 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?

    1-888-423-0139

  • Principal Display Panel

    COMPARE TO CHILDREN’S TRIAMINIC® MULTI-SYMPTOM FEVER & COLD

    ACTIVE INGREDIENTS

    TRIACTING SUSPENSION

    children’s Pain Relief Plus Multi-Symptom Cold

    OUR PHARMACISTS RECOMMEND

    FEVER REDUCER - PAIN RELIEVER - ACETAMINOPHEN

    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

    NASAL DECONGESTANT - PHENYLEPHRINE HCl

    ANTIHISTAMINE - CHLORPHENIRAMINE MALEATE

    Cold & Flu Symptom Relief

    Runny & Stuffy Nose

    Aches & Pains

    Fever

    Sore Throat

    Cough

    Ages 6 to under 12 Years

    GRAPE FLAVOR

    4 FL OZ (118 mL)

    childrens pain relief plus image
  • INGREDIENTS AND APPEARANCE
    TOPCARE COLD 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-903
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    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)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLE (opaque) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-903-261 in 1 CARTON07/24/2009
    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 finalpart34107/24/2009
    Labeler - Topco Associates LLC (006935977)
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