DAYCLEAR ALLERGY RELIEF (CHLOPHEDIANOL HCL, PYRILAMINE MALEATE) TABLET [GM PHARMACEUTICALS, INC]

DAYCLEAR ALLERGY RELIEF (CHLOPHEDIANOL HCL, PYRILAMINE MALEATE) TABLET [GM PHARMACEUTICALS, INC]
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NDC 58809-221-30
Set ID 4da2d858-6d7d-4afc-95f2-4a02b02281ff
Category HUMAN OTC DRUG LABEL
Packager GM Pharmaceuticals, INC
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    DAYCLEAR- ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET

    GM Pharmaceuticals, Inc.

    DayClear Allergy Relief Tablet 30 count

    Drug Facts

  • Active Ingredients (per tablet)

    Chlophedianol HCl 25 mg

    Pyrilamine Maleate 50 mg

  • Purpose

    Cough Suppressant

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy watery eyes
    • cough due to minor throat and bronchial irritation
  • Warnings

    Do not exceed recommended dosage.

    Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the 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
    • marked 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:

    • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
    • New symptoms occur

    If pregnant or breast-feeding,

    ask a health profession before use

    Keep out of reach of children.

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

  • Directions

    • do not take more than 4 doses per 24-hours
    • adults and children 12 years of age and over: 1 tablet every 6 to 8 hours
    • children 6 to under 12 years: 1/2 tablet every 6 to 8 hours
    • children under the age of 6: do not use
  • Other information

    • avoid excess heat and humidity
    • store at room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

  • Questions or Comments?

    Call 1-888-535-0305

    9 a.m. - 5 p.m. CST

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-221-30
    DAYCLEAR
    ALLERGY
    RELIEF
    30 TABLETS

    PRINCIPAL DISPLAY PANEL 
NDC 58809-221-30 
DAYCLEAR 
ALLERGY
RELIEF 
30 TABLETS

  • INGREDIENTS AND APPEARANCE
    DAYCLEAR ALLERGY RELIEF 
    chlophedianol hcl, pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE25 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code AC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-221-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/13/2018
    Labeler - GM Pharmaceuticals, INC (793000860)

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