NDC 54859-603

Tusnel DM Pediatric

Dextromethorphan, Guiafenesin, Pseudoephedrine Hcl

Tusnel DM Pediatric is a Oral Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is Guaifenesin; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID54859-603_7c6fd343-3dba-4754-b743-114e5ab4f072
NDC54859-603
Product TypeHuman Otc Drug
Proprietary NameTusnel DM Pediatric
Generic NameDextromethorphan, Guiafenesin, Pseudoephedrine Hcl
Dosage FormSolution/ Drops
Route of AdministrationORAL
Marketing Start Date1993-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLlorens Pharmaceutical International Division
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength25 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54859-603-02

60 mL in 1 BOTTLE, DROPPER (54859-603-02)
Marketing Start Date1993-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-603-02 [54859060302]

Tusnel DM Pediatric SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1993-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN25 mg/mL

OpenFDA Data

SPL SET ID:d915eab8-013e-4ce3-b358-0d531e5ca1ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1241674
  • NDC Crossover Matching brand name "Tusnel DM Pediatric" or generic name "Dextromethorphan, Guiafenesin, Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    54859-502TusnelDextromethorphan, Guiafenesin, Pseudoephedrine HCl
    54859-544TusnelDextromethorphan, Guiafenesin, Pseudoephedrine HCl
    54859-603Tusnel DMDextromethorphan, Guiafenesin, Pseudoephedrine HCl

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