NDC 37808-775

Cold Head Congestion Severe

Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride

Cold Head Congestion Severe is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Heb. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

Product ID37808-775_941da607-e93f-ad31-e053-2a95a90a8243
NDC37808-775
Product TypeHuman Otc Drug
Proprietary NameCold Head Congestion Severe
Generic NameAcetaminophen, Guaifenesin, And Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2018-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHEB
Substance NameACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 37808-775-02

2 BLISTER PACK in 1 CARTON (37808-775-02) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2018-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37808-775-02 [37808077502]

Cold Head Congestion Severe TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:c3849b66-697f-4f6e-93ab-76de031b3c70
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1243679
  • UPC Code
  • 0041220385874
  • NDC Crossover Matching brand name "Cold Head Congestion Severe" or generic name "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    37808-775Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    46122-415Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    63940-341Cold Head Congestion SevereCold Head Congestion Severe
    72036-175Cold Head Congestion SevereCold Head Congestion Severe
    36800-575Cold and 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
    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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