NDC 51660-566 Guaifenesin
Tablet, Extended Release Oral

Product Information

Guaifenesin is a human over the counter drug product labeled by Ohm Laboratories, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

Product Code51660-566
Proprietary Name 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.
Guaifenesin
Non-Proprietary Name 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.
Guaifenesin
Product Type 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.
Human Otc Drug
Dosage FormTablet, 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) 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.
Ohm Laboratories, Inc.
Labeler Code51660
FDA Application Number 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.
ANDA209254
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-01-2022
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Guaifenesin?


Product Characteristics

Color(s)WHITE (C48325 - BLUE/WHITE MOTTLED)
ShapeOVAL (C48345)
Size(s)16 MM
Imprint(s)RH;98
Score1

Product Packages

NDC 51660-566-21

Package Description: 20 TABLET, EXTENDED RELEASE in 1 CARTON

NDC 51660-566-41

Package Description: 40 TABLET, EXTENDED RELEASE in 1 CARTON

Product Details

What are Guaifenesin 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.

NDC to RxNorm Crosswalk

What is RxNorm? 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

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)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Pharmacologic Class(es)

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.

Guaifenesin Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



(in each extended-release tablet)

Guaifenesin, USP


Purpose



Expectorant


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Uses



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

Warnings



Do not use

  • •for children under 12 years of age
  • Ask a doctor before use if you have

    • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • •cough accompanied by too much phlegm (mucus)
    • Stop use and ask a doctor if

      • •cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache.
      •  These could be signs of serious illness.
      • If pregnant or breast-feeding, ask a health professional before use.


Directions



  • •do not crush, chew or break extended-release tablet
  • •take with a full glass of water
  • •this product can be administered without regard for the timing of meals
  • •adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
  • •children under 12 years of age: do not use.
  • Other information

    • •store between 20-25°C (68-77°F)
    • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
    • Keep the carton. It contains important information. See end panel for expiration date.

      †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.


Inactive Ingredients



colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone.


Questions



call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.


* Please review the disclaimer below.