MUCUS RELIEF DM- guaifenesin and dextromethorphan hydrobromide capsule, liquid filled

MUCUS RELIEF DM by

Drug Labeling and Warnings

MUCUS RELIEF DM by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC, MEDGEL PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)	Purposes
Guaifenesin 400mg	Expectorant
Dextromethorphan HBr 20mg	Cough Suppressant

Uses

• helps loosen phlegm (mucus)
• helps thin bronchial secretions to make coughs more productive

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 Doctor before use if you have

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

When using this product

• do not exceed recommended dosage
• do not 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 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older:

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

Other information

• 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
• you may report side effects to 1-888-333-9792

Inactive Ingredients

 gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Mucus Relief DM

COUGH

GUAIFENESIN 400 mg/EXPECTORANT
DEXTROMETHORPHAN HBr 20 mg/COUGH SUPPRESSANT

DISSOLVES QUICKLY

Controls cough
Thins & loosens mucus

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM 
guaifenesin and dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1930
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL (OBLONG)	Size	20mm
Flavor		Imprint Code	440
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-1930-4	4 in 1 CARTON	03/12/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68210-1930-1	1 in 1 CARTON	03/12/2020
2		10 in 1 BLISTER PACK; 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	03/12/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

Registrant - Spirit Pharmaceuticals LLC (179621011)