FDA Label for Mucus Relief Dm Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH IMMEDIATE-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,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Mucus Relief Dm Cough Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Immediate-Release Tablet)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Purpose
Cough suppressant
Expectorant
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 associated with the common cold
- the intensity of coughing
- the impulse to cough to help you get to sleep
Do Not Use
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
- cough accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
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 (1-800-222-1222) right away.
Directions
- take with a full glass of water
- adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: do not use
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Questions Or Comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 0904-6816-52
MucusRelief
DM COUGH
Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg
Cough Suppressant
Expectorant
• Controls Cough
• Thins and Loosens Mucus
Immediate Release
60 Tablets
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA
Rev. 09/18 M-17 Re-order No. 701016
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