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
  • 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 August 19, 2020

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

  • 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

  • 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 finalpart34108/19/2019
    Labeler - GM Pharmaceuticals, INC (793000860)