FDA Label for Leader Maximum Strength Mucus Relief Dm
View Indications, Usage & Precautions
Leader Maximum Strength Mucus Relief Dm Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 20 Ml)
Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg
Purpose
Cough Suppressant
Expectorant
Use(S)
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
.
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
When Using This Product
do not use more than directed
Stop Use And Ask 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 right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- Adults & children 12 years & older: 20 mL every 4 hours
- Children under 12 years of age: Do not use
Other Information
- each 20 mL contains: potassium 20 mg, sodium 20 mg
- store between 15-30°C (59-86°F)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum
Package Label.Principal Display Panel
LEADER™
NDC 70000-0465-1
Maximum Strength
Mucus
Relief DM
Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg
Cough Suppressant / Expectorant
For Ages 12 & Over
Multi-Symptom
Relieves Chest Congestion
Controls Cough
Thins and loosens Mucus
COMPARE TO MUCINEX FAST MAX DM MAX active ingredients*
6 FL OZ (177 mL)
* Please review the disclaimer below.