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    NDC 50580-0447-01 SUDAFED PE Head Congestion Plus Mucus 325; 200; 5 mg/1; mg/1; mg/1 Details

    SUDAFED PE Head Congestion Plus Mucus 325; 200; 5 mg/1; mg/1; mg/1

    SUDAFED PE Head Congestion Plus Mucus is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 50580-0447
    Product ID 50580-447_f76846ba-d2da-2a39-e053-6294a90ab3f0
    Associated GPIs
    GCN Sequence Number 060554
    GCN Sequence Number Description guaifen/phenyleph/acetaminophn TABLET 200-5-325 ORAL
    HIC3 B3N
    HIC3 Description DECONGESTANT-ANALGESIC-EXPECTORANT COMBINATION
    GCN 26743
    HICL Sequence Number 023719
    HICL Sequence Number Description GUAIFENESIN/PHENYLEPHRINE HCL/ACETAMINOPHEN
    Brand/Generic Brand
    Proprietary Name SUDAFED PE Head Congestion Plus Mucus
    Proprietary Name Suffix n/a
    Non-Proprietary Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 325; 200; 5
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name Johnson & Johnson Consumer Inc.
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 50580-0447-01 (50580044701)

    NDC Package Code 50580-447-01
    Billing NDC 50580044701
    Package 2 BLISTER PACK in 1 CARTON (50580-447-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2019-06-17
    NDC Exclude Flag N
    Pricing Information N/A