NDC 51013-134 Daytime Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride Capsule, Liquid - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51013-134
Proprietary Name:
Daytime Cold And Flu
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name: [2]
Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Puracap Pharmaceutical Llc
    Labeler Code:
    51013
    FDA Application Number: [6]
    part341
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    04-26-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - CLEAR)
    Shape:
    CAPSULE (C48336)
    Size(s):
    20 MM
    Imprint(s):
    PC9
    Score:
    1

    Product Packages

    NDC Code 51013-134-01

    Package Description: 1 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

    Product Details

    What is NDC 51013-134?

    The NDC code 51013-134 is assigned by the FDA to the product Daytime Cold And Flu which is a human over the counter drug product labeled by Puracap Pharmaceutical Llc. The generic name of Daytime Cold And Flu is acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form. The product is distributed in a single package with assigned NDC code 51013-134-01 1 blister pack in 1 carton / 10 capsule, liquid filled 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 Daytime Cold And Flu?

    Do not take more than the recommended doseadults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.children under 12 years: do not use

    What are Daytime Cold And Flu 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 325 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.
    • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

    Which are Daytime Cold And Flu UNII Codes?

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

    Which are Daytime Cold And Flu 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 Daytime Cold And Flu?

    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: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
    • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
    • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

    Which are the Pharmacologic Classes for Daytime Cold And Flu?

    * 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]


    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".