NDC 51013-110

Maximum Strength Nighttime Cold/Flu Relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hci

Maximum Strength Nighttime Cold/Flu Relief is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

Product ID51013-110_6a7ee5f2-2e5b-45c7-8daf-9bdb64a1d56d
NDC51013-110
Product TypeHuman Otc Drug
Proprietary NameMaximum Strength Nighttime Cold/Flu Relief
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hci
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-02-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePuraCap Pharmaceutical LLC.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 51013-110-04

2 BLISTER PACK in 1 CARTON (51013-110-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-110-04 [51013011004]

Maximum Strength Nighttime Cold/Flu Relief CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-21

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:85327584-89a1-499c-a774-300da28a4d4a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1297288
  • NDC Crossover Matching brand name "Maximum Strength Nighttime Cold/Flu Relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hci"

    NDCBrand NameGeneric Name
    51013-110Maximum Strength Nighttime Cold/Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI
    69842-071Maximum Strength Nighttime Cold/Flu ReliefAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI

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