COLD AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]

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COLD AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]
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NDC 36800-890-62
Set ID 5e7d6c08-1123-4034-80cf-c69cf7b1e93c
Category HUMAN OTC DRUG LABEL
Packager TOP CARE (Topco Associates LLC)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each tablet)

    Chlorpheniramine Maleate 4 mg

    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine

    Nasal decongestant

  • Uses

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

    Ask a doctor before use if you have

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

    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
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur 
    • symptoms do not improve within 7 days or occur with a fever

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 hours
    • do not take more than 6 doses in any 24-hour period
      adults and children 12 years of age and older  take 1 tablet
      children 6 to under 12 years of age  take 1/2 tablet
      children under 6 years of age  consult a doctor
      children under 4 years of age  do not use
  • Other information

    • each tablet contains: calcium 10 mg
    • store between 15-30ºC (59-86ºF) 
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO ACTIFED® COLD & ALLERGY ACTIVE INGREDIENTS*

    MAXIMUM STRENGTH

    Cold & Allergy RELIEF

    CHLORPHENIRAMINE MALEATE, 4 mg - ANTIHISTMINE

    PHENYLEPHRINE HCI, 10 mg - NASAL DECONGESTANT

    RELIEF OF:

    • Nasal Congestion
    • Runny Nose
    • Sneezing
    • Itchy, Watery Eyes

    TABLETS

    For ages 6 years and older

    Does not contain Pseudoephedrine

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Actifed® Cold & Allergy.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    QUESTIONS? 1-888-423-0139

    topcare@topco.com   www.topcarebrand.com

  • Product Label

    Chlorpheniramine maleate 4 mg, Phenylephrine HCI 10 mg

    TOPCARE HEALTH Maximum Strength Cold & Allergy relief

  • INGREDIENTS AND APPEARANCE
    COLD AND ALLERGY 
    chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-890
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code T127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-890-6224 in 1 CARTON07/13/201612/30/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/13/201612/30/2022
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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