Label: DAYCLEAR ALLERGY RELIEF- chlophedianol hcl, pyrilamine maleate tablet

  • NDC Code(s): 58809-221-30
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 13, 2022

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  • 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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