Label: CHILDRENS DAYCLEAR ALLERGY COUGH CHEWABLES- chlophedianol hydrochloride, pyrilamine maleate tablet, chewable

  • NDC Code(s): 58809-223-24, 58809-223-60
  • 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 7, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

     (in each tablet)

    Chlophedianol HCl 12.5 mg

    Pyrilamine Maleate 12.5 mg

  • Purpose

    Suppressant

    Antihistamine

  • Uses

    ■ temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

    ■ itchy nose or throat   ■ sneezing   

    ■ itchy, watery eyes   ■ runny nose

    ■ cough due to minor throat and bronchial irritation

  • Warnings

    Ask a doctor before use if you have

    ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

    ■ glaucoma

    ■ difficulty in urination due to enlargement of the prostate gland

    ■ cough that occurs with too much phlegm (mucus)

    ■ a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor before use if you

    are taking sedatives or tranquilizers

    When using this product

    ■ do not use more than directed

    ■ marked drowsiness may occur

    ■ avoid alcoholic drinks

    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    ■ be careful when driving a motor vehicle  or operating machinery            

    ■ excitability may occur, especially in children

    Stop use and ask a doctor if

    ■ cough persists for more than 1 week, tends to recur, or is accompanied by a 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 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

    ■ do not exceed more than 4 doses per 24-hour period

    adults and children 12 years and older:        chew 2 tablets every 6 to 8 hours

    children 6 to under 12 years of age:             chew 1 tablet every 6 to 8 hours

    children under 6 years:       do not use.

  • Other information

    ■ read all product information before using

    ■ store at room temperature 20-30°C  (68-86°F)

  • Inactive ingredients

    crospovidone, flavor, L-menthol, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, stevia, sucralose

  • Questions or comments?

    Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

  • PRINCIPAL DISPLAY PANEL

    Children’s
    DayClear
    Allergy
    Cough
    Chewables
    Cool Blast
    24 Chewable Tablets

    PRINCIPAL DISPLAY PANEL
Children’s
DayClear
Allergy
Cough
Chewables
Cool Blast
24 Chewable Tablets

  • INGREDIENTS AND APPEARANCE
    CHILDRENS DAYCLEAR ALLERGY COUGH CHEWABLES 
    chlophedianol hydrochloride, pyrilamine maleate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-223
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorMINTImprint Code DC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-223-241 in 1 CARTON12/26/2019
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58809-223-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/26/2019
    Labeler - GM Pharmaceuticals, INC (793000860)