NDC 54859-602

Tusnel Pediatric

Guiafenesin, Pseudoephedrine Hcl

Tusnel 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.

Product ID54859-602_4d96e27d-d9fc-460f-bfbb-6dd7b9185251
NDC54859-602
Product TypeHuman Otc Drug
Proprietary NameTusnel Pediatric
Generic NameGuiafenesin, Pseudoephedrine Hcl
Dosage FormSolution/ Drops
Route of AdministrationORAL
Marketing Start Date2006-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLlorens Pharmaceutical International Division
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54859-602-02

60 mL in 1 BOTTLE, DROPPER (54859-602-02)
Marketing Start Date2006-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-602-02 [54859060202]

Tusnel Pediatric SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2006-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN25 mg/mL

OpenFDA Data

SPL SET ID:f9fe6883-6e10-4851-8acb-a6df6e862375
Manufacturer
UNII

NDC Crossover Matching brand name "Tusnel Pediatric" or generic name "Guiafenesin, Pseudoephedrine Hcl"

NDCBrand NameGeneric Name
54859-602Tusnel PediatricGuiafenesin, Pseudoephedrine HCl
54859-604Tusnel PediatricDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
54859-544Tusnel PediatricTusnel Pediatric

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