DailyMed - MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

NDC Code(s): 50844-633-11
Packager: L.N.K. International, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated April 17, 2025

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

Active ingredients (in each immediate-release tablet)
Dextromethorphan HBr 20 mg - Guaifenesin 400 mg

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Close
Purpose
Cough suppressant - Expectorant

Cough suppressant
Expectorant
Close
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 ...
- 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 associated with the common cold
  - the intensity of coughing
  - the impulse to cough to help you get to sleep
Close
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 ...
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
- cough accompanied by too much 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.

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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.

Close
Directions
take with a full glass of water - adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use
- take with a full glass of water
- adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: do not use
Close
Other information
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Close
Inactive ingredients
D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic ...

D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Close
Questions or comments?
1-800-426-9391

1-800-426-9391
Close
Principal display panel
Quality - +Plus - NDC 50844-633-11 - MUCUS RELIEF - DM COUGH - Dextromethorphan HBr, 20 mg - Guaifenesin, 400 mg - COUGH SUPPRESSANT - EXPECTORANT - • Thins and loosens mucus - • Controls cough - 60 ...

Quality
+Plus

NDC 50844-633-11

MUCUS RELIEF
DM COUGH

Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg

COUGH SUPPRESSANT
EXPECTORANT

• Thins and loosens mucus
• Controls cough

60 Tablets

ACTUAL
SIZE

50844 REV0118A53311
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

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

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Quality plus 44-533

Close

INGREDIENTS AND APPEARANCE

Product Information

MUCUS RELIEF DM COUGH dextromethorphan hbr and guaifenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-633
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;533
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50844-633-11	1 in 1 CARTON	08/07/2023
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/07/2023

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(50844-633, 50844-633)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(50844-633) , pack(50844-633)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(50844-633, 50844-633)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(50844-633)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(50844-633)

View All Sections

Published Date (What is this?)	Version	Files
Apr 18, 2025	4 (current)	download
Apr 12, 2024	3	download
Oct 9, 2023	2	download
Aug 8, 2023	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1147685	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet	PSN
2	1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD
3	1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY

Label: MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

Number of versions: 4

MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

MUCUS RELIEF DM COUGH- dextromethorphan hbr and guaifenesin tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.