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 Advanced Rx LLC, ELYSIUM PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (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 make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help you get to sleep

Warnings

Do not use

• for children under 12 years 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 a 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 is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmcists before use if you are takingsedatives or tranquilizers

When using this productdo not use more than directed

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

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 20° - 25°C (68° - 77°F)
• Keep in dry place and do not expose to heat
• do not use if imprinted safety seal under the cap is broken or missing.

Inactive ingredients

Colloidal Silicon Dioxide, Hypromellose 5 & 15, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, PEG 400, PVP K30, Purified Water, Sodium Starch Glycolate, Stearic Acid Powder.

Questions?

call toll free  1-800-630-8895

Distributed by:

ADVANCED RX LLC

1942 NE 163ST North Miami Beach,

FL 33162 U.S.A

PRINCIPAL DISPLAY PANEL

NDC: 80513-407-09

*Compare to Mucine ® DM active ingredients

Mucus Relief DM

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Cough Suppresant & Expectorant

90 Tablets

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex ® DM Tablets.

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM 
guaifenesin, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-407
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)

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: 80513-407-09	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2025

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(80513-407)