NDC 0031-8765 Robitussin Maximum Strength 12 Hour Cough And Mucus Relief

Dextromethorphan Hydrobromide, Guaifenesin

  1. Labeler Index
  2. Wyeth Consumer Healthcare Llc
  3. NDC: 0031-8765 Robitussin Maximum Strength 12 Hour Cough And Mucus Relief

NDC Product Code 0031-8765

NDC CODE: 0031-8765

Proprietary Name: Robitussin Maximum Strength 12 Hour Cough And Mucus Relief 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):
YELLOW (C48330)
Shape: OVAL (C48345)
Size(s):
22 MM
Imprint(s):
2424
Score: 1

NDC Code Structure

NDC 0031-8765-04

Package Description: 1 BLISTER PACK in 1 CARTON > 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 0031-8765-08

Package Description: 1 BLISTER PACK in 1 CARTON > 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 0031-8765-16

Package Description: 2 BLISTER PACK in 1 CARTON > 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief with NDC 0031-8765 is a a human over the counter drug product labeled by Wyeth Consumer Healthcare Llc. The generic name of Robitussin Maximum Strength 12 Hour Cough And Mucus Relief is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Wyeth Consumer Healthcare Llc

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.

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.

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief 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 60 mg/1
  • GUAIFENESIN 1200 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.
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • COPOVIDONE K25-31 (UNII: D9C330MD8B)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Wyeth Consumer Healthcare Llc
Labeler Code: 0031
FDA Application Number: ANDA207602 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 06-14-2019 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’.

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Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Product Label Images

Robitussin Maximum Strength 12 Hour Cough And Mucus Relief 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: Pfizer, Madison, NJ 07940 USA

Otc - Purpose

Active ingredients (in each extended-release tablet)PurposesDextromethorphan HBr 60 mgCough suppressantGuaifenesin 1200 mgExpectorant

Indications & Usage

  • Useshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productivetemporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep

Warnings

Warnings

Do Not Use

  • For children under 12 years of ageif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough accompanied by too much phlegm (mucus)

When Using This Product

  • Do not use more than directed

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 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 (1-800-222-1222).

Dosage & Administration

  • Directionsdo not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for timing of mealsadults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years of age: do not use

Storage And Handling

  • Other informationeach tablet contains: magnesium 25 mgstore between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientscarbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide

Otc - Questions

Questions?call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

* Please review the disclaimer below.