NDC 51660-567 Guaifenesin
Tablet, Extended Release Oral

Product Information

What is NDC 51660-567?

The NDC code 51660-567 is assigned by the FDA to the product Guaifenesin which 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. The product is distributed in 3 packages with assigned NDC codes 51660-567-54 14 tablet, extended release in 1 carton , 51660-567-58 56 tablet, extended release in 1 carton , 51660-567-86 28 tablet, extended release in 1 carton . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code	51660-567
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 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) 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 Code	51660
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	51660 - Ohm Laboratories, Inc. 51660-567 - Guaifenesin 51660-567-54 51660-567-58 51660-567-86

What are the uses for Guaifenesin?

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).

Product Characteristics

Color(s)	WHITE (C48325 - BLUE/WHITE MOTTLED)
Shape	OVAL (C48345)
Size(s)	16 MM
Imprint(s)	RH;98 RH;99
Score	1

Product Packages

NDC Code 51660-567-54

Package Description: 14 TABLET, EXTENDED RELEASE in 1 CARTON

NDC Code 51660-567-58

Package Description: 56 TABLET, EXTENDED RELEASE in 1 CARTON

NDC Code 51660-567-86

Package Description: 28 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 1200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

Guaifenesin Active Ingredients UNII Codes

GUAIFENESIN (UNII: 495W7451VQ)
GUAIFENESIN (UNII: 495W7451VQ) (Active Moiety)

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

Guaifenesin 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.

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.

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Guaifenesin Product Label

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.

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.