NDC 11673-339 Maximum Strength Daytime Severe And Nighttime Cold And Flu

Daytime- Acetaminophen,Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hci,Nightime - - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
11673-339
Proprietary Name:
Maximum Strength Daytime Severe And Nighttime Cold And Flu
Non-Proprietary Name: [1]
Daytime- Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Nightime - Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Labeler Code:
11673
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
05-01-2024
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 11673-339?

The NDC code 11673-339 is assigned by the FDA to the product Maximum Strength Daytime Severe And Nighttime Cold And Flu which is a human over the counter drug product labeled by Target Corporation. The generic name of Maximum Strength Daytime Severe And Nighttime Cold And Flu is daytime- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nightime - acetaminophen, diphenhydramine hci, phenylephrine hci. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 11673-339-01 1 kit in 1 kit * 177 ml in 1 bottle, plastic * 177 ml in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Maximum Strength Daytime Severe And Nighttime Cold And Flu?

Nighttimedo not take more than directed (see overdose warning) do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing devicekeep dosing cup with productmL = mililiterdose as follows or as directed by a doctoradults and children 12 years and older: 20 mL every 4 hours while symptoms lastchildren under 12 years of age: do not useDaytimedo not take more than directed (see Overdose warning)do not take more than 6 doses in any 24-hours periodmeasure only with dosing cup provided. Do not use any other dosing device.dose as follows or as directed by a doctor keep dosing cup with product mL = milliliteradults and children 12 years of age and older: 20 mL every 4 hourschildren under 12 years of age: do not use

Which are Maximum Strength Daytime Severe And Nighttime Cold And Flu UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Maximum Strength Daytime Severe And Nighttime Cold And Flu Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Maximum Strength Daytime Severe And Nighttime Cold And Flu?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1116572 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1116572 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution
  • RxCUI: 1116572 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".