MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablets tablet

Mucus Relief DM by

Drug Labeling and Warnings

Mucus Relief DM by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA LLC, Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Immediate Release Mucus Relief DM 

Active Ingredients 

• Guaifenesin 400mg
• Dextromethorphan HBr 15mg 

Purpose 

Expectorant, Cough Suppressant 

Uses

• Helps loosen phlegm (mucus)
• Helps thin bronchial secretions to make coughs more productive
• Temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold 

Warnings

Do not use: 

• If you are now taking a prescriprion 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 

• Persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• Cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• Taking sedatives or Tranquilizers

When using this product

• Do not exceed recommended dosage
• Do ot use for more than 7 days

Stop use and ask a doctor if 

• Cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistant 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 overdosage, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and over: Take 1 Tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
• Children under 12 years: Do not use

Other Information

• Each Tablet contains: sodium 1.24 mg VERY LOW SODIUM
• store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
• Keep in a dry place and do not expose to heat
• Read all product information before using 
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

• Colloidal silicon dioxide
• Magnesium stearate
• Microcrystalline Cellulose
• Sodium starch glycolate

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Immediate Release Mucus Relief DMGuaifenesin 400mg / ExpectorantDextromethorphan HBr 15 mg/ Cough Suppressant Controls CoughThins and Loosens Mucus 12 Tablets  Distributed by:Healthlife of USA LLCRahwayNJ 07065www.healthlifeofusa.com

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM 
guaifenesin, dextromethorphan hbr tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-120-12	1 in 1 CARTON	05/31/2017
1		12 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/31/2017

Labeler - Healthlife of USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Healthlife of USA LLC		079656178	relabel(69517-120)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		915664486	manufacture(69517-120) , pack(69517-120)