MUCUS RELIEF DM- dextromethorphan hbr 20mg guaifenesin 400mg tablet

Mucus Relief DM by

Drug Labeling and Warnings

Mucus Relief DM by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222).

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 20ºC-25ºC (68ºF-77ºF).

• 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

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Reckitt Benckiser’s, owner of the registered trademark MUCINEX DM® Tablets.

SPL UNCLASSIFIED SECTION

Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM 
dextromethorphan hbr 20mg guaifenesin 400mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-027
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
microcrystalline cellulose (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	ET16
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-027-01	150 in 1 BOTTLE; Type 0: Not a Combination Product	10/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/04/2024

Labeler - Pioneer Life Sciences, LLC (014092742)