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
Active Ingredients (In Each Extended-Release Tablet)
Dextromethorphan HBr 30 mg
Guaifenesin 600 mg
- 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 under12 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).
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regards for timing of meals
- adults and children 12 years of age and older: 1 or 2 tablet every 12 hours; not more than 4 tablets in 24 hours
- children under 12 years of age: do not use
store between 20° to 25°C (68° to 77°F)
carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO MUCINEX® DM active ingredients*
Mucus Relief DM
Dextromethorphan HBr, 30 mg
Guaifenesin, 600 mg
Cough Suppressant | expectorant
Thins & Loosens Mucus
*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of Mucinex® DM.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
©2019 Cardinal Health
LEADER Mucus Relief DM
* Please review the disclaimer below.