Cold plus Flu Congestion Severe

Product NDC
83324-114
11-digit product format
833240114
Labeler code
83324
Product ID
83324-114_1f193f57-c3a8-efce-e063-6394a90a3b9c
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-07
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-114-24833240114242 BLISTER PACK in 1 CARTON (83324-114-24) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2024-08-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
1175-QCH-2024-0807CHAIN DRUG MARKETING ASSOCIATION, INC.2024-08-07HUMAN OTC DRUG LABEL2