NDC 0067-8151 Excedrin Extra Strength And Excedrin Tension Headache

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

Product Information

NDC Product Code:
0067-8151
Proprietary Name:
Excedrin Extra Strength And Excedrin Tension Headache
Non-Proprietary Name: [1]
Acetaminophen, Aspirin (nsaid), And Caffeine
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
FDA Application Number: [6]
M013
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
09-30-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
WHITE (C48325 - WHITE)
Shape:
OVAL (C48345)
CAPSULE (C48336)
Size(s):
17 MM
18 MM
Imprint(s):
ETH
E
Score:
1

Product Packages

NDC Code 0067-8151-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 1 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 0067-8151?

The NDC code 0067-8151 is assigned by the FDA to the product Excedrin Extra Strength And Excedrin Tension Headache which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Excedrin Extra Strength And Excedrin Tension Headache is acetaminophen, aspirin (nsaid), and caffeine. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0067-8151-01 1 kit in 1 package, combination * 1 bottle in 1 carton (0067-8139-01) / 24 tablet, film coated in 1 bottle * 1 bottle in 1 carton (0067-2000-91) / 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 Extra Strength And Excedrin Tension Headache?

•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 hours•children under 12 years: ask a doctor •do not use more than directed•drink a full glass of water with each dose•adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours•children under 12 years: ask a doctor

Which are Excedrin Extra Strength And Excedrin Tension Headache UNII Codes?

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

Which are Excedrin Extra Strength 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 Extra Strength 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: 209468 - EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet
  • RxCUI: 209468 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]
  • RxCUI: 209468 - APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]
  • RxCUI: 209468 - Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet
  • RxCUI: 209468 - Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet

* 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".