NDC 0067-8138 Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough

Acetaminophen,Dextromethorphan Hbr,Phenylephrine Hcl,Diphenhydramine Hcl Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0067-8138
Proprietary Name:
Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl
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]
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code:
0067
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
07-05-2016
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
18 MM
Imprint(s):
1143D
1143N
Score:
1
Flavor(s):
MINT (C73404)

Product Packages

NDC Code 0067-8138-40

Package Description: 1 KIT in 1 CARTON * 2 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

Product Details

What is NDC 0067-8138?

The NDC code 0067-8138 is assigned by the FDA to the product Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough is acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0067-8138-40 1 kit in 1 carton * 2 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack * 2 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack. 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 Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough?

•do not use more than directed•adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor•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 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor•children under 12 years of age: do not use

Which are Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough UNII Codes?

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

Which are Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough 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 Theraflu Expressmax Daytime Severe Cold And Cough And Theraflu Expressmax Nighttime Severe Cold And Cough?

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: 1094538 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1094538 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1233575 - acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1233575 - acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet

* Please review the disclaimer below.

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]


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]


Diphenhydramine


Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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]


Phenylephrine


Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]


* 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".