Label: CHILDRENS PEDIACLEAR PD- triprolidine hydrochloride liquid

  • NDC Code(s): 58809-651-50
  • 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 March 25, 2022

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  • SPL UNCLASSIFIED SECTION

    CHILDREN’S PEDIACLEAR PD

    NDC 58809-651-50

    Drug Facts

  • Active ingredients (in each 2 mL)

    Triprolidine HCI 1.25 mg

  • Purpose

    Antihistamine

  • Uses

    ■ temporarily relieves these symptoms due to hay fever

    (allergic rhinitis) or other upper respiratory allergies:

    ■ runny nose ■ itching of the nose or throat

    ■ sneezing ■ itchy, watery eyes

  • Warnings

    Do not exceed recommended dosage.

    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

    ■ excitability may occur, especially in children

    ■ marked drowsiness may occur

    ■ sedatives and tranquilizers may increase the drowsiness effect

    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

    ■ use only with enclosed dropper   ■ mL= milliliter

    ■ do not use dropper for any other drug product

    children 6 to under 12 years: 2 mL every 6 hours, not to exceed 4 doses in 24 hours, or as directed by a doctor.

    children under 6: ask a doctor.

  • Other information

    ■ 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, sodium saccharin, sorbitol solution

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 58809-651-50

    Children’s

    PediaClear

    PD

    Drops

    1.69 fl oz (50 mL)

    Label

    cartononsert

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PEDIACLEAR PD 
    triprolidine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-651
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 2 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-651-5050 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2019
    Labeler - GM Pharmaceuticals, INC (793000860)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM, LLC080000294manufacture(58809-651)
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