Cold and Flu Severe

Product NDC

68016-512

11-digit product format

680160512

Labeler code

68016

Product ID

68016-512_af0cbb19-c0fb-85a0-e053-2995a90afbf7

Type

HUMAN OTC DRUG

Nonproprietary name

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

Dosage form

TABLET, COATED

Route

ORAL

Labeler

CHAIN DRUG CONSORTIUM

Application

part341

Marketing category

OTC MONOGRAPH FINAL

Marketing start

2012-08-01

Marketing end

0000-00-00

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

Active strength

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

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record