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    NDC 00485-0240-01 ED-A-HIST DM 4; 10; 10 mg/1; mg/1; mg/1 Details

    ED-A-HIST DM 4; 10; 10 mg/1; mg/1; mg/1

    ED-A-HIST DM is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 00485-0240
    Product ID 0485-0240_02941928-1289-2c88-e063-6294a90ac6ba
    Associated GPIs 43995803120328
    GCN Sequence Number 073065
    GCN Sequence Number Description chlorpheniramine/phenyleph/DM TABLET 4-10-10 MG ORAL
    HIC3 B3R
    HIC3 Description NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST
    GCN 37388
    HICL Sequence Number 000375
    HICL Sequence Number Description CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN
    Brand/Generic Brand
    Proprietary Name ED-A-HIST DM
    Proprietary Name Suffix n/a
    Non-Proprietary Name CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 4; 10; 10
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name EDWARDS PHARMACEUTICALS, INC.
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 00485-0240-01 (00485024001)

    NDC Package Code 0485-0240-01
    Billing NDC 00485024001
    Package 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0240-01)
    Marketing Start Date 2014-10-27
    NDC Exclude Flag N
    Pricing Information N/A