Label: TRIPROLIDINE HYDROCHLORIDE liquid

  • 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 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 1 mL dropperful)

    Triprolidine HCl 0.938 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • 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
    • may cause drowsiness
    • sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if

    • new symptoms occur

    Keep out of the reach of children.

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

  • Directions

    Do not exceed recommended dosage.

    ■ use only with enclosed dropper
    ■ do not use enclosed dropper for any other drug product
    ■ mL= milliliter
    ■ Professional Labeling: Take under guidance of Health Professionals.

    AGEDOSE
    Childen 4 to under 6 years of age:1 dropperful (1.0 mL) every 4 to 6 hours, not to exceed 4 doses (4.0 mL) in 24 hours, or as directed by a Doctor.
    Children 2 to under 4 years of age⅔ dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours, or as directed by a Doctor.
    Infants 4 months to under 2 years of age⅓ dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours, or as directed by a Doctor.
  • Other Information

    • store at room temperature 15-30°C (59-86°F)
    • Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.
  • Inactive ingredients

    bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium
    sorbate, propylene glycol, propylparaben, purified water, sucralose

  • Questions? Comments?

    Call 1-844-696-6627 9 a.m. - 5 p.m. CST.

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton


    Do not use if foil seal
    under cap is missing or
    broken.
    Usual Dosage:
    See attached labeling for
    complete product
    information.
    store at °30-15C
    (°86-68F)


    KEEP OUT OF REACH
    OF CHILDREN.


    This product
    includes professional
    labeling for medical
    practioners only.

    Manufactured by:
    Monarch PCM, LLC.
    Fort Worth, TX 76118

    PDP

    Drug Facts

  • INGREDIENTS AND APPEARANCE
    TRIPROLIDINE HYDROCHLORIDE 
    triprolidine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70154-204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE0.938 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    AMMONIUM GLYCYRRHIZINATE TRIHYDRATE (UNII: 78NEL3149I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70154-204-3030 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 finalM01208/19/201910/31/2024
    Labeler - Monarch PCM, LLC (080000294)
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