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    NDC 70868-0740-16 Miclara DM 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL Details

    Miclara DM 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL

    Miclara DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Key Therapeutics. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.

    Product Information

    NDC 70868-0740
    Product ID 70868-740_d67cf0cc-7c79-8640-e053-2995a90a7b1e
    Associated GPIs 43995803960920
    GCN Sequence Number 072192
    GCN Sequence Number Description triprolidine/phenylephrine/DM LIQUID 2.5-10-20 ORAL
    HIC3 B3R
    HIC3 Description NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST
    GCN 36311
    HICL Sequence Number 041030
    HICL Sequence Number Description TRIPROLIDINE HCL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR
    Brand/Generic Brand
    Proprietary Name Miclara DM
    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 20; 10; 2.5
    Active Ingredient Units mg/5mL; mg/5mL; mg/5mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
    Labeler Name Key Therapeutics
    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 2023-12-31

    Package

    NDC 70868-0740-16 (70868074016)

    NDC Package Code 70868-740-16
    Billing NDC 70868074016
    Package 473 mL in 1 BOTTLE (70868-740-16)
    Marketing Start Date 2020-09-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c86e012b-17d0-4ffd-b815-9c07771bfaf1 Details

    Revised: 1/2022