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    NDC 54859-0508-16 Triponel 15; 5; 1.25 mg/5mL; mg/5mL; mg/5mL Details

    Triponel 15; 5; 1.25 mg/5mL; mg/5mL; mg/5mL

    Triponel is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.

    Product Information

    NDC 54859-0508
    Product ID 54859-508_bce65e4f-a4b1-4b28-b6f9-ac1f614dec82
    Associated GPIs
    GCN Sequence Number 085428
    GCN Sequence Number Description triprolidine/phenylephrine/DM LIQUID 1.25-5MG/5 ORAL
    HIC3 B3R
    HIC3 Description NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST
    GCN 54906
    HICL Sequence Number 041030
    HICL Sequence Number Description TRIPROLIDINE HCL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR
    Brand/Generic Brand
    Proprietary Name Triponel
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route ORAL
    Active Ingredient Strength 15; 5; 1.25
    Active Ingredient Units mg/5mL; mg/5mL; mg/5mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
    Labeler Name LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 54859-0508-16 (54859050816)

    NDC Package Code 54859-508-16
    Billing NDC 54859050816
    Package 474 mL in 1 BOTTLE (54859-508-16)
    Marketing Start Date 2019-08-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL cc774d33-96ce-4992-ad30-3cb03b0d119d Details

    Revised: 12/2019