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

NDC Code(s): 46122-790-61
Packager: Amerisource Bergen

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 23, 2024

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

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

Cough suppressant
Expectorant
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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
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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.

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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
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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
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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

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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal display panel (What is this?)
GOOD - NEIGHBOR - PHARMACY® NDC 46122-790-61 - Mucus Relief DM COUGH - Cough Relief - Dextromethorphan HBr, 20 mg / Cough Suppressant - Guaifenesin, 400 mg / Expectorant - • Controls Cough • Thins and ...

GOOD
NEIGHBOR
PHARMACY®

NDC 46122-790-61

Mucus Relief DM COUGH

Cough Relief

Dextromethorphan HBr, 20 mg / Cough Suppressant
Guaifenesin, 400 mg / Expectorant

• Controls Cough • Thins and Loosens Mucus • Immediate Release

50 Tablets

actual size

Distributed By
AmerisourceBergen
1 West First Avenue,
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

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

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

Good Neighbor Pharmacy 44-533

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INGREDIENTS AND APPEARANCE

Product Information

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-790
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:46122-790-61	1 in 1 CARTON	07/23/2024
1		50 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	07/23/2024

Labeler - Amerisource Bergen (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(46122-790)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(46122-790) , pack(46122-790)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(46122-790)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(46122-790)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(46122-790)

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	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, guaifenesin tablet, film coated

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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, 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, guaifenesin tablet, film coated

Number of versions: 1

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

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

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

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