NDC 0536-1312 Rugby Chest Congestion Relief DM

Dextromethorphan Hydrobromide / Guaifenesin

NDC Product Code 0536-1312

NDC CODE: 0536-1312

Proprietary Name: Rugby Chest Congestion Relief DM 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: Dextromethorphan Hydrobromide / 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Guaifenesin is used to treat coughs and congestion 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. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. 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)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
PH073
Score: 2

NDC Code Structure

  • 0536 - Rugby Laboratories

NDC 0536-1312-08

Package Description: 60 TABLET in 1 BOTTLE

NDC Product Information

Rugby Chest Congestion Relief DM with NDC 0536-1312 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Rugby Chest Congestion Relief DM is dextromethorphan hydrobromide / guaifenesin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Rugby Laboratories

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.

Rugby Chest Congestion Relief DM 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
  • GUAIFENESIN 400 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)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • 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.
  • 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: Rugby Laboratories
Labeler Code: 0536
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: 09-01-2020 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: 12-31-2021 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.

Rugby Chest Congestion Relief DM Product Label Images

Rugby Chest Congestion Relief DM 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

Otc - Active Ingredient

Active ingredient - (per tablet)Dextromethorphan Hydrobromide   20mgGuaifenesin  400mg

Otc - Purpose

PurposeCough SuppressantExpectorant

Uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus■ Helps make coughs more productive.

Warnings

Do not use  ■ if you are now taking a
prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for
depression, psychiatric or emotional conditioners or Parkinson's
disease)or for 2 weeks after stopping MAIO drug, If you do not know if
your prescription drug contains an MAIO, ask your doctor or pharmacist
before using this product.

Otc - Ask Doctor

Ask doctor before use if you have■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma■ cough is accompanied by excessive phlegm (mucus)

Otc - Stop Use

Stop use and ask doctor if■ symptoms are accompanied by fever, rash or persistent headache■ cough persists for more than 1 week or tends to recur. A persistent cough may be a sign of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In  case of overdose, get medical help or contact a Poison Center immediately.

Dosage & Administration

Directions■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.■ Children under 6 years of age: consult a doctor.    Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

Store at 15°-30°C (59°-86°F)

Inactive Ingredient

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide,
(co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate,
stearic acid.

* Please review the disclaimer below.