FDA Label for Mucus Relief Dm
View Indications, Usage & Precautions
Mucus Relief Dm Product Label
The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, Llc. 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 Ingredient (In Each Tablet)
Dextromethorphan HBr 20 mg
Guaifenesin 400mg
Purpose
Dextromethorphan HBr 20 mg ......................................... Cough suppressant
Guaifenesin 400mg ........................................................................ 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
o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
o the intensity of coughing
o the impulse to cough to help you get to sleep
Warnings:
Do Not Use
- for children under 12 year 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 sign of serious illness.
Directions:
Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours.
Children under 12 years of age: Do not use
Other Information:
Store between 20°C-25°C (68°F-77°F).
- Keep in a dry place and do not expose to heat
- do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredients:
microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow
Questions Or Comments?
Call (732) 698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.com
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