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

NDC Code(s): 70000-0278-1, 70000-0278-2
Packager: Cardinal Health 110, LLC. DBA Leader

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated May 8, 2025

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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
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN - see end flap for expiration date and lot number - store at 25°C (77°F); excursions permitted between ...
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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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
LEADER™ NDC 70000-0278-1 - Maximum Strength - Mucus Relief - DM Cough - Dextromethorphan HBr, 20 mg ι Guaifenesin, 400 mg - Cough Suppressant ι Expectorant - Controls Cough - Thins and Loosens ...

LEADER™

NDC 70000-0278-1

Maximum Strength
Mucus Relief
DM Cough

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

Controls Cough
Thins and Loosens Mucus

Immediate-Release
Tablets

24 TABLETS

ACTUAL SIZE

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

50844 REV0118A53308

CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

© 2022 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health
LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of
Cardinal Health.

√ All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

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

Leader 44-533

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INGREDIENTS AND APPEARANCE

Product Information

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0278
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	Marketing End Date
Packaging
1	NDC:70000-0278-1	2 in 1 CARTON	12/31/2005
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0278-2	1 in 1 CARTON	12/31/2005	12/04/2022
2		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	12/31/2005

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(70000-0278)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(70000-0278) , pack(70000-0278)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(70000-0278)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(70000-0278)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(70000-0278)

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Published Date (What is this?)	Version	Files
Jun 5, 2025	15 (current)	download
May 13, 2024	14	download
Oct 9, 2023	13	download
May 4, 2023	12	download
Jun 2, 2022	11	download
Jun 29, 2021	10	download
May 10, 2021	8	download
Oct 13, 2020	6	download
Oct 23, 2019	5	download
Apr 8, 2019	4	download
Apr 3, 2018	3	download
May 1, 2017	2	download
Mar 27, 2017	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 MAXIMUM STRENGTH- dextromethorphan hbr and 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

	NDC
1	70000-0278-1
2	70000-0278-2

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

Number of versions: 13

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

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

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MUCUS RELIEF DM COUGH MAXIMUM STRENGTH- 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.