NDC 66576-335

Giltuss TR

Guaifenesin,dextromethorphan Hbr,phenylephrine Hcl

Giltuss TR is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Syntho Pharmaceuticals, Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID66576-335_e1502b49-a051-2c07-e053-2995a90a3151
NDC66576-335
Product TypeHuman Otc Drug
Proprietary NameGiltuss TR
Generic NameGuaifenesin,dextromethorphan Hbr,phenylephrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-01-07
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart341
Labeler NameSyntho Pharmaceuticals, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength29 mg/1; mg/1; mg/1
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 66576-335-01

100 TABLET in 1 BOTTLE (66576-335-01)
Marketing Start Date2022-01-07
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Giltuss TR" or generic name "Guaifenesin,dextromethorphan Hbr,phenylephrine Hcl"

NDCBrand NameGeneric Name
58552-335Giltuss TRGuaifenesin,Dextromethorphan HBr,Phenylephrine HCl
66576-335Giltuss TRGuaifenesin,Dextromethorphan HBr,Phenylephrine HCl

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