Theraflu Flu Relief Maximum Strength Kit
NDC 0067-8161

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0067-8161?
  5. Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Theraflu Flu Relief Maximum Strength (acetaminophen, dextromethorphan hbr and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr) is a OTC MONOGRAPH DRUG-approved product labeled by Haleon Us Holdings Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a red kit. This product entry covers the primary NDC 0067-8161 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0067-8161
Proprietary Name:
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hbr And Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Haleon Us Holdings Llc
Labeler Code:
0067
Product Label ID:
68d3e88a-d1be-410b-92a1-863903b3aa61
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
06-27-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326)
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
18 MM
Imprint(s):
DT;1
NT;1
Score:
1

Code Structure Chart

Product Details

What is NDC 0067-8161?

The NDC code 0067-8161 is assigned by the FDA to the product Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack. It is commonly known by its generic name, acetaminophen, dextromethorphan hbr and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr. This pharmaceutical product is labeled by Haleon Us Holdings Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0067-8161-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

•do not use more than directed•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist•do not take more than 6 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use •do not use more than directed•Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist•do not take more than 6 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 1098496 - acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 1098496 - acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet
  • RxCUI: 1098496 - APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet
  • RxCUI: 247324 - acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 247324 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet

* Please review the full disclaimer at the bottom of this page.

Patient Education

Acetaminophen


Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]


Chlorpheniramine


Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]


Dextromethorphan


Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".