NDC 0067-6095 Theraflu Powerpods Nighttime Severe Cold

Acetaminophen,Diphenhydramine Hcl,Phenylephrine Hcl Powder, For Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0067-6095
Proprietary Name:
Theraflu Powerpods Nighttime Severe Cold
Non-Proprietary Name: [1]
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name: [2]
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Haleon Us Holdings Llc
    Labeler Code:
    0067
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    07-28-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    HONEY (C73394)
    LEMON (C73396)

    Product Packages

    NDC Code 0067-6095-01

    Package Description: 8 POUCH in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6095-02)

    NDC Code 0067-6095-03

    Package Description: 1 POUCH in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 POUCH

    Product Details

    What is NDC 0067-6095?

    The NDC code 0067-6095 is assigned by the FDA to the product Theraflu Powerpods Nighttime Severe Cold which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Theraflu Powerpods Nighttime Severe Cold is acetaminophen, diphenhydramine hcl, phenylephrine hcl. The product's dosage form is powder, for solution and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0067-6095-01 8 pouch in 1 carton / 1 powder, for solution in 1 pouch (0067-6095-02), 0067-6095-03 1 pouch in 1 carton / 1 powder, for solution in 1 pouch. 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 Powerpods Nighttime Severe Cold?

    •do not use more than directed•take every 4 hours, while symptoms persist. Do not take more than 5 pods in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone podchildren under 12 years of agedo not use•do not remove the foil seal as the pod will not work properly and could result in hot water burns •place pod in compatible brewer•use a minimum of 8 oz. of water•when finished, the pod will be hot and may drip. Tilt the pod during removal to avoid dripping.•remove used pod and flush brewer after each use with a minimum of 8 oz. of water•sip while hot. Consume entire drink within 10-15 minutes.

    What are Theraflu Powerpods Nighttime Severe Cold Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ACETAMINOPHEN 650 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
    • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
    • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

    Which are Theraflu Powerpods Nighttime Severe Cold UNII Codes?

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

    Which are Theraflu Powerpods Nighttime Severe Cold 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 Powerpods Nighttime Severe Cold?

    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: 1659960 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution
    • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
    • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution
    • RxCUI: 1659960 - acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
    • RxCUI: 1659960 - APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution

    Which are the Pharmacologic Classes for Theraflu Powerpods Nighttime Severe Cold?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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]


    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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".