Cold plus Head Congestion Severe

Product NDC
68998-275
11-digit product format
689980275
Labeler code
68998
Product ID
68998-275_2527750e-324a-4fc3-e063-6394a90a4aa0
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-05
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
68998-275-02689980275022 BLISTER PACK in 1 CARTON (68998-275-02) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2022-10-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
1175-MAR-2022-1005MARC GLASSMAN, INC.2024-10-23HUMAN OTC DRUG LABEL3