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 ID: 50580-680_760330ed-4a48-4345-b117-8769564158a6
• NDC: 50580-680
• Product Type: Human Otc Drug
• Proprietary Name: SUDAFED PE Pressure PLUS Pain PLUS Mucus
• Generic Name: Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50580-680-25

2 BLISTER PACK in 1 CARTON (50580-680-25) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-680-25 [50580068025]

SUDAFED PE Pressure PLUS Pain PLUS Mucus TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 7fb3d350-baff-46d0-8fd4-6d9fecfbd63b
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• 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"

NDC	Brand Name	Generic Name
50580-680	SUDAFED PE Pressure PLUS Pain PLUS Mucus	SUDAFED PE Pressure PLUS Pain PLUS Mucus
36800-575	Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-775	Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-415	Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-275	COLD RELIEF SEVERE HEAD CONGESTION	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-793	Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-712	Head Congestion Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-573	head congestion plus mucus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-273	Mucus and Sinus PE	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-267	mucus relief sinus severe congestion and pain	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-712	Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-367	Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-512	Pressure and Pain PE Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-773	Pressure Plus Pain PE Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-788	PRESSURE plus PAIN plus MUCUS	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-789	SEVERE COLD HEAD CONGESTION	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-505	Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49348-117	Sinus Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-229	Sinus Relief Congestion and Pain Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41250-219	sinus severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
46122-412	Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
49738-119	Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
50405-009	SohMed Sinus	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
50580-447	SUDAFED PE Head Congestion Plus Mucus	acetaminophen, guaifenesin, and phenylephrine hydrochloride
50066-305	Tukol Max Action Sinus Liquid	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
50580-507	Tylenol Sinus Severe	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride