NDC 10135-681 Guaifenesin 200mg

Guaifenesin

NDC Product Code 10135-681

NDC Code: 10135-681

Proprietary Name: Guaifenesin 200mg What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Guaifenesin 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
G2
Score: 1

NDC Code Structure

  • 10135 - Marlex Pharmaceuticals Inc
    • 10135-681 - Guaifenesin 200mg

NDC 10135-681-01

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Guaifenesin 200mg with NDC 10135-681 is a a human over the counter drug product labeled by Marlex Pharmaceuticals Inc. The generic name of Guaifenesin 200mg is guaifenesin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Marlex Pharmaceuticals Inc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Guaifenesin 200mg Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GUAIFENESIN 200 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Marlex Pharmaceuticals Inc
Labeler Code: 10135
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 03-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Guaifenesin 200mg Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Guaifenesin 200mg

Purpose

ExpectorantGuaifenesin 200 mg Tablets

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Warnings

  • Ask a doctor before use if you havePersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemaCough accompanied by too much phlegm (mucus)

Stop Use And Ask A Doctor If

Cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

If Pregnant Or Breast- Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

  • Do not take more than 6 doses in any 24-hour period.This product is not intended for use in children under 12 years of ageAdults & children 12 years and over: 1 to 2 tablets every 4 hoursChildren under 12 years: do not use

Other Information:

  • Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acidManufactured for & Distributed by:Marlex Pharmaceuticals, Inc.New Castle, DE 19720Rev: 02/19TCL

* Please review the disclaimer below.

Previous Code
10135-680
Next Code
10135-682