Active Ingredient(S)(In Each Extended-Release Tablet)
Active ingredient (in each extended-release tablet)
Dextromethorphan HBr 60 mg
Guaifenesin 1200 mg
Guaifenesin And Dextromethorphan Hbr Tablet, Extended Release
FDA Label NDC 65162-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amneal Pharmaceuticals Llc for the product Guaifenesin And Dextromethorphan Hbr (NDC 65162-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s)(in each extended-release tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Guaifenesin - Expectorant
Dextromethorphan HBr - Cough suppressant
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
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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)
Directions
1200 mg/60 mg
- 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
Other Information
- Bottle: Tamper evident: Do not use if carton is open or if printed foil under cap is broken or missing
- Blister: Do not use if carton is open or if printed seal with product name on blister is broken or missing
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
Questions?
1-877-835-5472
You may also report side effects to this phone number.
Parents:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Keep the carton. It contains important information.
See end panel for expiration date.
†Mucinex® is a registered trademark of Reckitt Benckiser LLC.
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 04-2018-01
* Please review the disclaimer below.
