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    NDC 63824-0503-64 Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL Details

    Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL

    Mucinex Nightshift is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE.

    Product Information

    NDC 63824-0503
    Product ID 63824-503_e9071387-8850-436c-badc-a087a899e0ac
    Associated GPIs 43998903302020
    GCN Sequence Number 080838
    GCN Sequence Number Description triprolidine/DM/acetaminophen LIQUID 2.5-650/20 ORAL
    HIC3 B4G
    HIC3 Description NON-OPIOID ANTITUS-1ST GEN ANTIHIST-ANALGESIC COMB
    GCN 47819
    HICL Sequence Number 046405
    HICL Sequence Number Description TRIPROLIDINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN
    Brand/Generic Brand
    Proprietary Name Mucinex Nightshift
    Proprietary Name Suffix Cold and Flu
    Non-Proprietary Name Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 650; 20; 2.5
    Active Ingredient Units mg/20mL; mg/20mL; mg/20mL
    Substance Name ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
    Labeler Name RB Health (US) LLC
    Pharmaceutical Class Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 63824-0503-64 (63824050364)

    NDC Package Code 63824-503-64
    Billing NDC 63824050364
    Package 1 BOTTLE in 1 CARTON (63824-503-64) / 118 mL in 1 BOTTLE
    Marketing Start Date 2019-06-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a51b6312-598e-4a25-a873-6b59bc87d900 Details

    Revised: 1/2022