Label: TOPCARE COLD AND ALLERGY- chlorpheniramine maleate and phenylephrine hydrochloride tablet, film coated 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/09

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

  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

    Phenylephrine HCl 10 mg

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  • Purpose

    Antihistamine

    Nasal decongestant

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  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • nasal congestion
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
    • nasal congestion
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  • Warnings

    Do not use

    • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • to make a child sleepy

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    adults and children 12 years and over
    • take 1 tablet every 4 to 6 hours
    • do not take more than 6 tablets in 24 hours
    children under 12 years do not use this product in children under 12 years of age
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  • Inactive ingredients

    carnauba wax, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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  • Questions or comments?

    1-888-423-0139

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  • Principal Display Panel

    See New Dosing Directions

    One-Tablet Dose

    Cold & Allergy

    Chlorpheniramine Maleate/Antihistamine

    Phenylephrine HCl/Nasal Decongestant

    Relieves

    Nasal Congestion

    Runny Nose

    Sneezing

    Itchy, Watery Eyes

    Actual Size

    Compare to Actifed® Cold & Allergy Active Ingredients

    Cold & Allergy Carton

    Cold & Allergy Carton

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  • INGREDIENTS AND APPEARANCE
    TOPCARE COLD AND ALLERGY 
    chlorpheniramine maleate, phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-139
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code L358
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-139-62 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/12/2006
    Labeler - Topco Associates LLC (006935977)
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