Label: CAREONE ALLERGY RELIEF- chlorpheniramine maleate tablet

  • NDC Code(s): 41520-463-62
  • Packager: American Sales Company
  • 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 August 28, 2017

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  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

  • Purpose

    Antihistamine

  • Uses

    •
    temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
    •
    sneezing
    •
    runny nose
    •
    itchy, watery eyes
    •
    itching of the nose or throat
  • Warnings

    Do not use

    to make a child sleepy

    Ask a doctor before use if you have

    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    glaucoma

    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

    •
    excitability may occur, especially in children
    •
    drowsiness may occur
    •
    avoid alcoholic beverages
    •
    alcohol, sedatives and tranquilizers may increase drowsiness

    use caution when driving a motor vehicle or operating machinery

    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).

  • Directions

    adults and children 12 years and over

    1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours

    children 6 to under 12 years of age

    ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

    children 4 to under 6 years of age

    do not use unless directed by a doctor

    children under 4 years of age

    do not use

    Other information

    •
    store at 20-25°C (68-77°)
  • Inactive ingredients

    D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Chlor-Trimeton® Allergy 4 Hour Tablets

    4hr

    Allergy Relief

    Chlorpheniramine Maleate, 4mg

    Antihistamine

    Actual Size

    24 TABLETS

    4 HOUR RELIEF OF:

    Sneezing – Runny Nose – Itchy, Watery Eyes – Itchy Throat

    OUR PHARMACISTS RECOMMEND

    Gluten Free

    Allergy Relief Image
  • INGREDIENTS AND APPEARANCE
    CAREONE ALLERGY RELIEF 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-463
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorYELLOWScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code L463
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-463-621 in 1 CARTON05/18/2004
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/18/2004
    Labeler - American Sales Company (809183973)
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