Label: DAYCLEAR ALLERGY RELIEF- allergy releif liquid

  • NDC Code(s): 58809-211-08
  • 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 June 2, 2022

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  • SPL UNCLASSIFIED SECTION

    Dayclear allergy releif 8oz

  • ACTIVE INGREDIENT

    Active Purpose
    ingredients
    (in each 30 mL)
    Chlophedianol Cough
    HCl 25 mg ............... suppressant
    Pyrilamine Maleate
    50 mg .................... Antihistamine

  • INDICATIONS & USAGE

    temporarily relieves these
    symptoms due to the common
    cold, hay fever (allergic rhinitis) or
    other upper respiratory allergies:
    ▪ cough due to minor throat and
    bronchial irritation
    ▪ runny nose
    ▪ sneezing
    ▪ itching of the nose or throat
    ▪ itchy, watery eyes

  • WARNINGS AND PRECAUTIONS

    Do not exceed recommended
    dosage.

  • ASK DOCTOR

    ▪ 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

  • PREGNANCY OR BREAST FEEDING

    ask a
    health professional
    before use.

  • OVERDOSAGE

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

  • DOSAGE & ADMINISTRATION

    ▪ do not exceed
    recommended dosage.
    ▪ do not take more than 4
    doses in any 24-hour
    period.
    ▪ use enclosed dose cup
    ▪ keep dosage cup with
    product
    ▪ mL = milliliter
    ▪ adults and children 12
    years and over: 30 mL
    every 6-8 hours
    ▪ children under 12: do
    not use

  • OTHER SAFETY INFORMATION

    each 30 mL contains:
    Sodium 17 mg.
    ▪ tamper evident: Do not
    use if foil seal under cap
    is broken or missing.
    ▪ read all product
    information before
    using.

  • STORAGE AND HANDLING

    ▪ store at 68 to 86°F
    (20 to 30°C).
    ▪ avoid excessive heat
    and humidity

  • INACTIVE INGREDIENT

    citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

  • QUESTIONS

    Call 1-888-535-0305

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Do not exceed recommended dosage

  • PURPOSE

    temporarily relieves these
    symptoms due to the common
    cold, hay fever (allergic rhinitis) or
    other upper respiratory allergies:
    ▪ cough due to minor throat and
    bronchial irritation
    ▪ runny nose
    ▪ sneezing
    ▪ itching of the nose or throat
    ▪ itchy, watery eyes

  • PRINCIPAL DISPLAY PANEL

    Principal display label

    Dayclear allergy releif 8oz

    NDC 58809-211-08

    princpal display label

    princpal display label-2princpal display label-3

  • INGREDIENTS AND APPEARANCE
    DAYCLEAR ALLERGY RELIEF 
    allergy releif liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-211
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE50 mg  in 30 mL
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE25 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-211-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2017
    Labeler - GM Pharmaceuticals INC (793000860)
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