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    NDC 54859-0606-01 Tusnel-DM Pediatric 2.5; 25; 1.25 mg/mL; mg/mL; mg/mL Details

    Tusnel-DM Pediatric 2.5; 25; 1.25 mg/mL; mg/mL; mg/mL

    Tusnel-DM Pediatric 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 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 54859-0606
    Product ID 54859-606_e0fc03c4-634f-4ba2-a194-9a350d7b2937
    Associated GPIs 43997303100937
    GCN Sequence Number 081519
    GCN Sequence Number Description guaifen/dextromethorphan/PE DROPS 25-2.5/ML ORAL
    HIC3 B4R
    HIC3 Description NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
    GCN 48657
    HICL Sequence Number 000216
    HICL Sequence Number Description GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
    Brand/Generic Brand
    Proprietary Name Tusnel-DM Pediatric
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION/ DROPS
    Route ORAL
    Active Ingredient Strength 2.5; 25; 1.25
    Active Ingredient Units mg/mL; mg/mL; mg/mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 54859-0606-01 (54859060601)

    NDC Package Code 54859-606-01
    Billing NDC 54859060601
    Package 30 mL in 1 BOTTLE, DROPPER (54859-606-01)
    Marketing Start Date 2019-08-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 64e36b02-b5be-4d20-8818-cb5b23596671 Details

    Revised: 12/2019