NDC 55045-3143 Mucinex

NDC Product Code 55045-3143

NDC CODE: 55045-3143

Proprietary Name: Mucinex 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.

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.

  • 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 AND WHITE)
Shape: OVAL (C48345)
Size(s):
16 MM
Imprint(s):
MUCINEX;600
Score: 1

NDC Code Structure

  • 55045 - Dispensing Solutions, Inc.

NDC 55045-3143-2

Package Description: 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Mucinex with NDC 55045-3143 is a product labeled by Dispensing Solutions, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 636522 and 891301.

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.

  • CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Labeler Information

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

Labeler Name: Dispensing Solutions, Inc.
Labeler Code: 55045
Start Marketing Date: 05-12-2010 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)

Why is guaifenesin medication prescribed?
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 cla...
[Read More]

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Mucinex 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

Other

Drug Facts

Distributed by:Reckitt Benckiser Inc.Parsippany, NJ 07054-0224©RBI 2009

Active Ingredient (In Each Extended-Release Bi-Layer Tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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

Otc - Do Not Use

  • Do not usefor children under 12 years of age

Otc - Ask Doctor

  • 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)

Otc - Stop Use

  • Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 Control Center right away.

Directions

  • Do not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for the timing of mealsadults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.children under 12 years of age: do not use

Other Information

  • Tamper evident: do not use if carton is open or if printed seal on blister is broken or missingstore between 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

1-866-MUCINEX (1-866-682-4639)You may also report side effects to this phone number.

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