NDC 63940-330

Sinus Severe

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

Sinus Severe is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Harmon Stores Inc.. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

Product ID63940-330_94834978-f5b9-283f-e053-2a95a90af39c
NDC63940-330
Product TypeHuman Otc Drug
Proprietary NameSinus Severe
Generic NameAcetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2018-09-11
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHarmon Stores Inc.
Substance NameACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63940-330-02

2 BLISTER PACK in 1 CARTON (63940-330-02) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2018-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63940-330-02 [63940033002]

Sinus Severe TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-11

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:68d86b88-b305-43a1-8923-010cb2c27a24
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1243679
  • UPC Code
  • 0099581911652
  • NDC Crossover Matching brand name "Sinus Severe" or generic name "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    11673-927Sinus SevereAcetaminophen, Guaifenesin, Phenylephrine HCl
    41250-219sinus severeACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    46122-412Sinus SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    49738-119Sinus SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    50804-672Sinus SevereSinus Severe
    56062-460sinus severesinus severe
    63940-330Sinus SevereSinus Severe
    72036-119Sinus SevereSinus Severe
    68016-504Sinus SevereSinus 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
    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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