NDC 50580-507

Tylenol Sinus Severe

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

Tylenol Sinus Severe is a Oral Tablet, 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 ID50580-507_1d9bedd5-6dbd-4a79-861c-a92491c36dae
NDC50580-507
Product TypeHuman Otc Drug
Proprietary NameTylenol Sinus Severe
Generic NameAcetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2015-05-15
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 Through2021-12-31

Packaging

NDC 50580-507-01

2 BLISTER PACK in 1 CARTON (50580-507-01) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2015-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-507-01 [50580050701]

Tylenol Sinus Severe TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-05-15

NDC 50580-507-03 [50580050703]

Tylenol Sinus Severe TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-17

NDC 50580-507-04 [50580050704]

Tylenol Sinus Severe TABLET, COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-17

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

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

NDCBrand NameGeneric Name
29485-8055TYLENOL SINUS SEVEREACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
29485-8057TYLENOL SINUS SEVEREACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
50269-507Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
50580-507Tylenol Sinus SevereTylenol Sinus Severe
67414-507Tylenol Sinus SevereTylenol Sinus Severe
73097-014Tylenol Sinus SevereTylenol Sinus Severe
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

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