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  4. NDC Product Code: 0067-8147 Excedrin Pm Triple Action Caplets And Excedrin Tension Headache

NDC 0067-8147 Excedrin Pm Triple Action Caplets And Excedrin Tension Headache

Acetaminophen,Aspirin (nsaid),Caffeine,And Diphenhydramine Citrate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0067-8147?
  5. Excedrin Pm Triple Action Caplets And Excedrin Tension Headache Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0067-8147
Proprietary Name:
Excedrin Pm Triple Action Caplets And Excedrin Tension Headache
Non-Proprietary Name: [1]
Acetaminophen, Aspirin (nsaid), Caffeine, And Diphenhydramine Citrate
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]
Haleon Us Holdings Llc
Labeler Code:
0067
Product Label ID:
978a9d27-6d41-42cb-a193-11314923d2ac
FDA Application Number: [6]
M013
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
06-01-2017
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE)
RED (C48326)
Shape:
RECTANGLE (C48347)
OVAL (C48345)
Size(s):
17 MM
Imprint(s):
EXPM
ETH
Score:
1

Code Structure Chart

Product Details

What is NDC 0067-8147?

The NDC code 0067-8147 is assigned by the FDA to the product Excedrin Pm Triple Action Caplets And Excedrin Tension Headache which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Excedrin Pm Triple Action Caplets And Excedrin Tension Headache is acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0067-8147-01 1 kit in 1 package, combination * 1 bottle in 1 carton (0067-2056-24) / 24 tablet, coated in 1 bottle * 1 bottle in 1 carton (0067-8139-02) / 100 tablet, film coated in 1 bottle. 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 Excedrin Pm Triple Action Caplets And Excedrin Tension Headache?

•do not use more than directed•do not use in children under 12 years of age•adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water•do not take more than 2 caplets in 24 hours, unless directed by a doctor •do not use more than directed•adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hourschildren under 12 years: ask a doctor

Which are Excedrin Pm Triple Action Caplets And Excedrin Tension Headache UNII Codes?

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

Which are Excedrin Pm Triple Action Caplets And Excedrin Tension Headache 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 Excedrin Pm Triple Action Caplets And Excedrin Tension Headache?

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: 1593110 - acetaminophen 250 MG / aspirin 250 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
  • RxCUI: 1593110 - acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet
  • RxCUI: 1593110 - APAP 250 MG / ASA 250 MG / Diphenhydramine Citrate 38 MG Oral Tablet
  • RxCUI: 1593116 - Excedrin PM Triple Action (250 MG / 250 MG / 38 MG) Oral Tablet
  • RxCUI: 1593116 - acetaminophen 250 MG / aspirin 250 MG / diphenhydramine citrate 38 MG Oral Tablet [Excedrin PM Triple Action]

* 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".