NDC 42961-112 Xpect Cold Relief

Acetaminophen Guaifenesein Phenylephrine Hcl Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
42961-112
Proprietary Name:
Xpect Cold Relief
Non-Proprietary Name: [1]
Acetaminophen Guaifenesein Phenylephrine Hcl
Substance Name: [2]
Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Cintas Corporation
    Labeler Code:
    42961
    FDA Application Number: [6]
    M013
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    03-29-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    ROUND (C48348)
    Size(s):
    12 MM
    Score:
    1

    Product Packages

    NDC Code 42961-112-11

    Package Description: 80 PACKET in 1 BOX / 2 TABLET in 1 PACKET (42961-112-10)

    NDC Code 42961-112-12

    Package Description: 200 PACKET in 1 BOX / 2 TABLET in 1 PACKET (42961-112-10)

    Product Details

    What is NDC 42961-112?

    The NDC code 42961-112 is assigned by the FDA to the product Xpect Cold Relief which is a human over the counter drug product labeled by Cintas Corporation. The generic name of Xpect Cold Relief is acetaminophen guaifenesein phenylephrine hcl. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 42961-112-11 80 packet in 1 box / 2 tablet in 1 packet (42961-112-10), 42961-112-12 200 packet in 1 box / 2 tablet in 1 packet (42961-112-10). 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 Xpect Cold Relief?

    • Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not exceed 8 tablets in 24 hours, or as directed by a doctor.• Children under 12 years: Consult a doctor

    What are Xpect Cold Relief 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.
    • GUAIFENESIN 200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
    • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

    Which are Xpect Cold Relief UNII Codes?

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

    Which are Xpect Cold Relief 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 Xpect Cold Relief?

    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: 1243679 - acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
    • RxCUI: 1243679 - acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
    • RxCUI: 1243679 - APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
    • RxCUI: 1243679 - APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet

    Which are the Pharmacologic Classes for Xpect Cold Relief?

    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]


    Guaifenesin


    Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
    [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".