Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Mucus Relief Dm Solution
FDA Label NDC 70000-0707
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 (NDC 70000-0707). 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 20 ml), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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
- 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
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 that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
cough persists more than 1 week, 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 right away.
Directions
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- dose as follows or as directed by a doctor
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- each 20 mL contains: sodium 6 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
LEADER♥™
NDC 70000-0707-1
Maximum Strength
Mucus
Relief DM
Guaifenesin
Dextromethorphan HBr
Cough Suppressant | Expectorant
Berry
Flavored
For Ages 12 Years
and Over
Controls Cough
Relieves Chest
Congestion
Thins & Loosens
Mucus
COMPARE TO
MAXIMUM STRENGTH
MUCINEX® FAST-MAX®
DM MAX
active ingredients*
100% Money Back Guarantee
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by RB
Health (US) LLC, owner of the registered trademark
Maximum Strength Mucinex® FAST-MAX® DM MAX.
50844 ORG042403145
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
©2024 CARDINAL HEALTH, LEADER, and LOGOs are
trademarks of Cardinal Health. All other marks are the
property of their respective owners.
100% Money Back Guarantee
Return to place of purchase if not satisfied.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Leader 44-031a (Leader 44 031a 1)
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