HABEN HERB (CHLORPHENIRAMINE MALEATE) CAPSULE [BEVERLY HILLS HOLDINGS CO,. LTD.]

HABEN HERB (CHLORPHENIRAMINE MALEATE) CAPSULE [BEVERLY HILLS HOLDINGS CO,. LTD.]
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NDC 69195-1001-1
Set ID 569cfe1e-a9ed-4c85-94e7-1f42d5b1897a
Category HUMAN OTC DRUG LABEL
Packager Beverly Hills Holdings Co,. Ltd.
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    chlorpheniramine maleate, acetaminophen, pseudoephedrine hydrochloride, cloperastin hydrochloride, lysozyme hydrochloride, guaifenesin, thiamine nitrate, riboflavin, platycodon 50% ethanol dried extract, cinnamon dried extract, glycyrrhize dried extract


  • INACTIVE INGREDIENT

    povidone, light anhydrous silicic acid, magnesium stearate


  • PURPOSE

    - temporarily relieves these cold symptomes
    runny nose, nasal congestion, sneezing, sore throat, cough, sputum, headache, minor aches and pain
    - temporarily reduces fever


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    Adults and children 15 years or over: take 2 capsules after meal 3 times a day
    Children between 8 and 14 years: take 1 capsule after meal 3 times a day


  • WARNINGS

    [DO NOT USE]
    if you are hypersensitive to this drug and any component of this drug
    if you have a history of asthma after taking this drug, other cold drugs or antipyreticanalgesics
    in infants under 3 months of age
    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
    with antitussive expectorants, other cold medicines, antipyretic-analgesics, sedatives,
    antihistamines(certain drugs for rhinitis, preventive drugs for travel sickness, allergies)

    [ASK A DOCTOR OR PHARMACIST BEFORE USE]
    in infants or children under 15 years infected with chickenpox or influenza
    in infants under 2 years of age only when it is necessary. Inform to the guardian/s and
    monitor closely while administering
    if you are genetically prone to uticaria, contact dermatitis, bronchial asthma, allergic rhinitis,
    migraine, food allergy
    If you have allergic reactions (e.g., fever, rash, arthralgia, asthma, itch, etc.) to this drug and
    any component of this drug
    if you have liver disease, kidney disease, heart disease, thyroid disease, diabetes, high blood
    pressure, edema, stomach-duodenal ulcer, glaucoma, dysuria, high fever
    if you are elderly or week
    if you have bleeding , ache and discomfort in stomach
    If (possibly) pregnant or breast-feeding
    If you are taking a prescription drug for diabetes, goat, arthritis, anticoagulants and steroids
    if you have cough by smoking, asthma, chronic bronchitis, emphysema, cough accompanied
    with excessive sputum, fever, rash, persistent headache and cough lasting more than 1 week,
    recurrent cough or chronic cough

    [STOP USE AND ASK A DOCTOR IF]
    you experience any of the following symptoms:
    rash, redness, itching, nausea, vomiting, loss of appetite, constipation, edema, dysuria, severe
    or persistent thirst, dizziness, anxiety, shivering, insomnia
    you experience any of the following severe symptoms:
    anaphylaxis (e.g., immediate rash, edema, shortness of breath along with paling of face,
    cold sweat, cold hands and feet)
    Stevens-Johnson syndrome (mucocutaneous syndrome) or Lyell syndrome (toxic epidermal
    necrosis) (e.g., rash and redness accompanied with high fever, blisters as in burn over the
    body or mucous membranes of mouth or eyes) asthma
    liver dysfunction (e.g., drowsiness, jaundice)
    interstitial pneumonia (e.g., shortness of breath, fever accompanied with cough)
    aldosteronism: long-term continuous use of preparations containing over than 1g as licorice
    (daily maximum dose) may cause hypokalemia, increased blood pressure, fluid retention of
    sodium, edema, weight gain, aldosteronism. Observe closely (blood potassium concentration)
    and stop taking this drug and when you have above symptoms.
    myopathy may rarely occur as a result of hypokalemia. Observe closely and stop taking this
    drug when you appear symptoms such as weakness, limb spasms, and numbness.

    [WHEN USING THIS PRODUCT]
    do not exceed recommended dosage
    do not take for a long period of time
    administer to children under the guidance and supervision of a guardian
    avoid alcoholic drinks
    do not drive a motor vehicle or operate machinery
    barbiturates, tricyclic antidepressants, and alcohol may reduce the ability to metabolize large
    quantities of acetaminophen, thereby increasing the plasma half-life of acetaminophen
    myopathy may occur due to aldosteronism or hypokalemia when administered with drugs
    containing potassium, licorice, glycyrrhizin acid or its salts, loop diuretics (furosemide,
    ethacrynic acid) or thiazide diuretic (trichlormethiazide).

  • DOSAGE & ADMINISTRATION

    for oral administration


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    HABEN HERB 
    chlorpheniramine maleate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69195-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Coloryellow (Haben Herb) Score2 pieces
    ShapeCAPSULE (Haben Herb) Size20mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69195-1001-110 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/27/2014
    Labeler - Beverly Hills Holdings Co,. Ltd. (689061741)
    Registrant - Beverly Hills Holdings Co,. Ltd. (689061741)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korean Drug Co., Ltd.689276249manufacture(69195-1001)

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