MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablet

Mucus Relief DM by

Drug Labeling and Warnings

Mucus Relief DM by is a Otc medication manufactured, distributed, or labeled by PLD Acquisitions LLC DBA Avéma Pharma Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
• temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • intensity of coughing
  • the impulse to cough to help you get to sleep

Warnings

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 accopanied 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 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 exceed 6 doses in 24 hours
• take with a full glass of water 
• adults and children 12 years of age and older:
  • take 1 tablet every 4 hours
• children under 12 years of age: do not use 

Other information

• each tablet contains: sodium 20 mg low sodium
• store between 20-25ºC (68-77ºF)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Mucus Relief DM

Guaifenesin 400 mg

Expectorant

Dextromethorphan HBr 20 mg

Cough suppressant

• Controls Cough
• Thins and loosens mucus

Tablets

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Package Label

Mucus Relief DM

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM 
guaifenesin, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63548-0109
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	20 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	17mm
Flavor		Imprint Code	G2;G2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63548-0109-1	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/02/2010

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)