NDC 0031-8765 Robitussin Maximum Strength 12 Hour Cough And Mucus Relief
Dextromethorphan Hydrobromide, Guaifenesin Tablet, Extended Release Oral
Product Information
What is NDC 0031-8765?
The NDC code 0031-8765 is assigned by the FDA to the product Robitussin Maximum Strength 12 Hour Cough And Mucus Relief which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) 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. The product is distributed in 3 packages with assigned NDC codes 0031-8765-04 1 blister pack in 1 carton / 4 tablet, extended release in 1 blister pack, 0031-8765-08 1 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack, 0031-8765-16 2 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack. 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.
What are the uses for Robitussin Maximum Strength 12 Hour Cough And Mucus Relief?
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
Product Characteristics
Color(s) | YELLOW (C48330) |
Shape | OVAL (C48345) |
Size(s) | 22 MM |
Imprint(s) | 2424 |
Score | 1 |
Product Packages
NDC Code 0031-8765-04
Package Description: 1 BLISTER PACK in 1 CARTON / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC Code 0031-8765-08
Package Description: 1 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC Code 0031-8765-16
Package Description: 2 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Details
What are Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Active Ingredients?
- DEXTROMETHORPHAN HYDROBROMIDE 60 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
- GUAIFENESIN 1200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Active Ingredients UNII Codes
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- GUAIFENESIN (UNII: 495W7451VQ)
- GUAIFENESIN (UNII: 495W7451VQ) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1099074 - guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet
- RxCUI: 1099074 - 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet
- RxCUI: 1099074 - dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet
Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Inactive Ingredients UNII Codes
- 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)
Pharmacologic Class(es)
* Please review the disclaimer below.
Robitussin Maximum Strength 12 Hour Cough And Mucus Relief 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.
Product Label Table of Contents
- OTHER
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 1200 MG/60 MG TABLET BLISTER PACK
- PRINCIPAL DISPLAY PANEL - 8 TABLET BLISTER PACK CARTON
Other
Drug Facts
Distributed by: Pfizer, Madison, NJ 07940 USA
Otc - Purpose
Active ingredients (in each extended-release tablet) | Purposes |
---|---|
Dextromethorphan HBr 60 mg | Cough suppressant |
Guaifenesin 1200 mg | Expectorant |
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
Warnings
Do Not Use
- for children under 12 years of age
- if 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 emphysema
- cough 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
Directions
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
- children under 12 years of age: do not use
Storage And Handling
Other information
- each tablet contains: magnesium 25 mg
- store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
carbomer 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
Principal Display Panel - 1200 Mg/60 Mg Tablet Blister Pack
PUSH TABLET THROUGH FOIL
Robitussin® Maximum Strength
12 Hour Cough & Mucus Relief
Extended-Release Tablet
Guaifenesin 1200 mg
Dextromethorphan HBr 60 mg
Extended-Release Tablet
Dist. by: Pfizer, Madison, NJ 07940 USA
©2019 Pfizer Inc.
LOT
EXP
Principal Display Panel - 8 Tablet Blister Pack Carton
NEW!
Robitussin®
MAXIMUM STRENGTH
12 Hour
Cough & Mucus Relief
EXTENDED-RELEASE TABLETS
GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE
1200 mg/60 mg EXTENDED-RELEASE TABLETS
Expectorant & Cough Suppressant
Actual Size
✓Controls Cough
✓Thins & Loosens Mucus
8
EXTENDED-RELEASE TABLETS
* Please review the disclaimer below.