Severe Cold and Flu

Product NDC

63940-342

11-digit product format

639400342

Labeler code

63940

Product ID

63940-342_ee2affbc-63ca-96b0-e053-2995a90a94b6

Type

HUMAN OTC DRUG

Nonproprietary name

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Harmon Stores Inc.

Application

part341

Marketing category

OTC MONOGRAPH FINAL

Marketing start

2018-09-11

Marketing end

2024-07-31

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

0000-00-00

Current FDA listing

Historical FDA.report record