NDC 50580-680

SUDAFED PE Pressure PLUS Pain PLUS Mucus

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

SUDAFED PE Pressure PLUS Pain PLUS Mucus is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

Product ID50580-680_760330ed-4a48-4345-b117-8769564158a6
NDC50580-680
Product TypeHuman Otc Drug
Proprietary NameSUDAFED PE Pressure PLUS Pain PLUS Mucus
Generic NameAcetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50580-680-25

2 BLISTER PACK in 1 CARTON (50580-680-25) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2013-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-680-25 [50580068025]

SUDAFED PE Pressure PLUS Pain PLUS Mucus TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2013-07-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:7fb3d350-baff-46d0-8fd4-6d9fecfbd63b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1243679
  • UPC Code
  • 0300450580252
  • NDC Crossover Matching brand name "SUDAFED PE Pressure PLUS Pain PLUS Mucus" or generic name "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-680SUDAFED PE Pressure PLUS Pain PLUS MucusSUDAFED PE Pressure PLUS Pain PLUS Mucus
    36800-575Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-775Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    46122-415Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41250-275COLD RELIEF SEVERE HEAD CONGESTIONACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-793Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41163-712Head Congestion Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41250-573head congestion plus mucus PEACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41250-273Mucus and Sinus PEACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41250-267mucus relief sinus severe congestion and painACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    46122-712Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-367Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41163-512Pressure and Pain PE Plus MucusACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-773Pressure Plus Pain PE Plus MucusACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    49738-788PRESSURE plus PAIN plus MUCUSACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    49738-789SEVERE COLD HEAD CONGESTIONACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    36800-505Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    49348-117Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    46122-229Sinus Relief Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    41250-219sinus severeACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    46122-412Sinus SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    49738-119Sinus SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    50405-009SohMed SinusAcetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
    50580-447SUDAFED PE Head Congestion Plus Mucusacetaminophen, guaifenesin, and phenylephrine hydrochloride
    50066-305Tukol Max Action Sinus LiquidAcetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
    50580-507Tylenol Sinus SevereAcetaminophen, Guaifenesin, and Phenylephrine Hydrochloride

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