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    NDC 54859-0605-01 Tusnel Pediatric Drops 25; 1.25 mg/mL; mg/mL Details

    Tusnel Pediatric Drops 25; 1.25 mg/mL; mg/mL

    Tusnel Pediatric Drops is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. The primary component is GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 54859-0605
    Product ID 54859-605_47dff372-3f9d-48bc-86a3-5d0ee6b3d68e
    Associated GPIs 43996202100948
    GCN Sequence Number 081506
    GCN Sequence Number Description guaifenesin/phenylephrine HCl DROPS 25-1.25/ML ORAL
    HIC3 B4W
    HIC3 Description DECONGESTANT-EXPECTORANT COMBINATIONS
    GCN 48644
    HICL Sequence Number 000250
    HICL Sequence Number Description GUAIFENESIN/PHENYLEPHRINE HCL
    Brand/Generic Brand
    Proprietary Name Tusnel Pediatric Drops
    Proprietary Name Suffix n/a
    Non-Proprietary Name Guaifenesin, Phenylephrine HCl
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION/ DROPS
    Route ORAL
    Active Ingredient Strength 25; 1.25
    Active Ingredient Units mg/mL; mg/mL
    Substance Name GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], 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 54859-0605-01 (54859060501)

    NDC Package Code 54859-605-01
    Billing NDC 54859060501
    Package 30 mL in 1 BOTTLE, DROPPER (54859-605-01)
    Marketing Start Date 2019-08-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 Details

    Revised: 12/2019