Label: CHILDRENS PEDIACLEAR 8- pyrilamine maleate liquid

  • NDC Code(s): 58809-770-08
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 7, 2024

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  • SPL UNCLASSIFIED SECTION

    CHILDRENS PEDIACLEAR 8

    NDC: 58809-770-08

  • Active ingredients

     (in each 15 mL)

    Pyrilamine Maleate 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    ■ temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

  • Warnings

    Ask a doctor before use if the child has

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ glaucoma

    Ask a doctor before use if the child is

    taking sedatives or tranquilizers

    When using this product

    ■ marked drowsiness may occur

    ■ sedatives and tranquilizers may increase drowsiness

    ■ excitability may occur, especially in children

    Stop use and ask a doctor if

    new symptoms occur

    Keep out of reach of children.

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

  • Directions

    ■ mL= milliliter
    ■ use enclosed 15 mL dose cup and keep with product
    ■ children 6 to under 12 years: 30 mL (2 dose cups) every 6 to 8 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor
    ■ children under 6 years of age: consult a doctor.

  • Other information

    ■ each 15 mL contains: Sodium 6 mg
    ■ read all product information before using
    ■ this packaging is child-resistant
    ■ store at room temperature 20-30°C (68-86°F)

  • Inactive ingredients

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

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-770-08

    Children’s

    PediaClear

    8 Eight

    8 fl oz (237 mL)

    PDP1

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PEDIACLEAR 8 
    pyrilamine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-770
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE12.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-770-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/19/2019
    Labeler - GM Pharmaceuticals, INC (793000860)
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