NDC 50269-507

Tylenol Sinus Severe

Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride

Tylenol Sinus Severe is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Jc World Bell Wholesale Co., Inc.. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 50269-507_7acaa8ec-c5df-3b62-e053-2991aa0a2cc8
• NDC: 50269-507
• Product Type: Human Otc Drug
• Proprietary Name: Tylenol Sinus Severe
• Generic Name: Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-09-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: JC World Bell Wholesale Co., Inc.
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50269-507-25

25 POUCH in 1 BOX (50269-507-25) > 2 TABLET in 1 POUCH

• Marketing Start Date: 2018-09-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50269-507-25 [50269050725]

Tylenol Sinus Severe TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-09-20

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24
• Manufacturer:
  • JC World Bell Wholesale Co., Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679
• UPC Code:
  • 0852682507762

NDC Crossover Matching brand name "Tylenol Sinus Severe" or generic name "Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
29485-8055	TYLENOL SINUS SEVERE	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
29485-8057	TYLENOL SINUS SEVERE	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
50269-507	Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
50580-507	Tylenol Sinus Severe	Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
67414-507	Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
70264-026	TYLENOL SINUS SEVERE	ACETAMINOPHEN
73097-014	Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
53942-515	Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
67751-178	Handy Solutions Sinus Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
47682-168	Medique CCP Caffeine Free	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE