Active Ingredients (In Each Immediate-Release Tablet)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Mucus Relief Dm Cough Tablet, Film Coated
FDA Label NDC 70000-0278
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Mucus Relief Dm Cough (NDC 70000-0278). 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 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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 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 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 of age 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)
- see end flap for expiration date and lot number
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?
1-800-426-9391
Principal Display Panel
LEADER™
NDC 70000-0278-1
Maximum Strength
Mucus Relief
DM Cough
Dextromethorphan HBr, 20 mg ι Guaifenesin, 400 mg
Cough Suppressant ι Expectorant
Controls Cough
Thins and Loosens Mucus
Immediate-Release
Tablets
24 TABLETS
ACTUAL SIZE
100% Money Back Guarantee
50844 ORG061253308
CIN 5326137 REV. 3/17
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OH 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
© 2017 Cardinal Health. All Rights Reserved.
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LOGO, LEADER, and the Leader LOGO are
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Cardinal Health.
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Return to place of purchase if not satisfied
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