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    NDC 00485-0206-16 RYNEX PSE 1; 15 mg/5mL; mg/5mL Details

    RYNEX PSE 1; 15 mg/5mL; mg/5mL

    RYNEX PSE is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE.

    Product Information

    NDC 00485-0206
    Product ID 0485-0206_19ac8a3a-6e5f-4c5d-93f0-9aba74ef22f6
    Associated GPIs 43993002241003
    GCN Sequence Number 047576
    GCN Sequence Number Description brompheniramin/pseudoephedrine LIQUID 1-15MG/5ML ORAL
    HIC3 Z2N
    HIC3 Description 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
    GCN 12933
    HICL Sequence Number 000501
    HICL Sequence Number Description BROMPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL
    Brand/Generic Generic
    Proprietary Name RYNEX PSE
    Proprietary Name Suffix n/a
    Non-Proprietary Name BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route ORAL
    Active Ingredient Strength 1; 15
    Active Ingredient Units mg/5mL; mg/5mL
    Substance Name BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
    Labeler Name EDWARDS PHARMACEUTICALS, INC.
    Pharmaceutical Class Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2023-12-31

    Package

    NDC 00485-0206-16 (00485020616)

    NDC Package Code 0485-0206-16
    Billing NDC 00485020616
    Package 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16)
    Marketing Start Date 2011-03-07
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2f2d9b5a-f66b-4928-8d43-402ef9efcfdf Details

    Revised: 10/2022