NDC 68788-0845

Sinus Congestion PE

Guaifenesin And Phenylephrine Hcl

Sinus Congestion PE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

Product ID68788-0845_7957f9da-fbb5-410a-8b82-8a766ee8fb8c
NDC68788-0845
Product TypeHuman Otc Drug
Proprietary NameSinus Congestion PE
Generic NameGuaifenesin And Phenylephrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-05-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength400 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68788-0845-2

20 TABLET in 1 BOTTLE, PLASTIC (68788-0845-2)
Marketing Start Date2014-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-0845-3 [68788084503]

Sinus Congestion PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-14

NDC 68788-0845-6 [68788084506]

Sinus Congestion PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-14

NDC 68788-0845-2 [68788084502]

Sinus Congestion PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-14

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:31257238-a0b0-4f2c-98ea-c24b8a6dc30a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1304111
  • NDC Crossover Matching brand name "Sinus Congestion PE" or generic name "Guaifenesin And Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    11822-0542Sinus Congestion PEGuaifenesin and Phenylephrine HCl
    36800-631Sinus Congestion PEPHENYLEPHRINE HYDROCHLORIDE
    50844-443Sinus Congestion PEPhenylephrine HCl
    68788-0845Sinus Congestion PEGuaifenesin and Phenylephrine HCl
    68998-231Sinus Congestion PEPHENYLEPHRINE HYDROCHLORIDE
    79903-076Sinus Congestion PEPhenylephrine HCl
    50991-736Deconex IRGuaifenesin and Phenylephrine HCl
    58552-313Gilphex TRGuaifenesin and Phenylephrine HCl
    69168-354Mucus Relief DGuaifenesin and Phenylephrine HCl
    21130-542Mucus Relief PEGuaifenesin and Phenylephrine HCl
    0904-5792Mucus Relief SinusGuaifenesin and Phenylephrine HCl
    63187-587Mucus Relief SinusGuaifenesin and Phenylephrine HCl
    68788-7872Mucus Relief SinusGuaifenesin and Phenylephrine HCl

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