Multi-Symptom Cold Flu and Sore Throat

Product NDC

49035-616

Requested package NDC

49035-616-01

11-digit product format

490350616

Labeler code

49035

Product ID

49035-616_e9c8ae48-0df8-4165-a8ea-9240aa1fd991

Type

HUMAN OTC DRUG

Nonproprietary name

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Wal-Mart Stores Inc

Application

part341

Marketing category

OTC MONOGRAPH FINAL

Marketing start

2013-04-07

Marketing end

0000-00-00

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

Active strength

325 mg/1; mg/1; mg/1; mg/1

Pharmacologic classes

Adrenergic 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 flag

No

Listing certified through

2023-12-31

Current FDA listing

Historical FDA.report record