NDC 43598-008 Guaifenesin 600 Mg

Guaifenesin Tablet, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
43598-008
Proprietary Name:
Guaifenesin 600 Mg
Non-Proprietary Name: [1]
Guaifenesin
Substance Name: [2]
Guaifenesin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Dr. Reddy�s Laboratories Inc.
    Labeler Code:
    43598
    FDA Application Number: [6]
    ANDA215932
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    03-15-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - WHITE ON DEBOSSED SIDE AND LIGHT PINK TO PINK ON OTHER SIDE )
    Shape:
    OVAL (C48345)
    Size(s):
    16 MM
    Imprint(s):
    6
    Score:
    1

    Product Packages

    NDC Code 43598-008-01

    Package Description: 5 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)

    NDC Code 43598-008-10

    Package Description: 1000 TABLET, EXTENDED RELEASE in 1 POUCH

    NDC Code 43598-008-40

    Package Description: 2 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)

    NDC Code 43598-008-89

    Package Description: 1280 TABLET, EXTENDED RELEASE in 1 CASE

    NDC Code 43598-008-97

    Package Description: 64 BLISTER PACK in 1 CASE / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)

    Product Details

    What is NDC 43598-008?

    The NDC code 43598-008 is assigned by the FDA to the product Guaifenesin 600 Mg which is a human over the counter drug product labeled by Dr. Reddy�s Laboratories Inc.. The generic name of Guaifenesin 600 Mg is guaifenesin. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 43598-008-01 5 blister pack in 1 carton / 20 tablet, extended release in 1 blister pack (43598-008-20), 43598-008-10 1000 tablet, extended release in 1 pouch , 43598-008-40 2 blister pack in 1 carton / 20 tablet, extended release in 1 blister pack (43598-008-20), 43598-008-89 1280 tablet, extended release in 1 case , 43598-008-97 64 blister pack in 1 case / 20 tablet, extended release in 1 blister pack (43598-008-20). 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 Guaifenesin 600 Mg?

    This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

    What are Guaifenesin 600 Mg 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.
    • GUAIFENESIN 600 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
    • GUAIFENESIN 600 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

    Which are Guaifenesin 600 Mg UNII Codes?

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

    Which are Guaifenesin 600 Mg 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:

    • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
    • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
    • FERRIC OXIDE RED (UNII: 1K09F3G675)
    • HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
    • HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
    • HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
    • MAGNESIUM STEARATE (UNII: 70097M6I30)
    • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
    • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

    What is the NDC to RxNorm Crosswalk for Guaifenesin 600 Mg?

    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: 310621 - guaiFENesin 1200 MG 12HR Extended Release Oral Tablet
    • RxCUI: 310621 - 12 HR guaifenesin 1200 MG Extended Release Oral Tablet
    • RxCUI: 310621 - guaifenesin 1200 MG 12 HR Extended Release Oral Tablet
    • RxCUI: 636522 - guaiFENesin 600 MG 12HR Extended Release Oral Tablet
    • RxCUI: 636522 - 12 HR guaifenesin 600 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Guaifenesin 600 Mg?

    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

    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]


    * 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".