MUCUS RELIEF DM- dextromethorphan hbr and guiafenesin tablet, film coated
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Major 44-533-Discontinued

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
helps loosen phlegm (mucus) and 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 a doctor before use if you have

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

When using this product

do not use more than directed

Stop use and ask a doctor if

cough 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not exceed 6 doses in 24 hours
take with a full glass of water
adults and children 12 years of age and over: 1 tablet, every 4 hours
children under 12 years: do not use

Other information

store at controlled room temperature 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

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

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-6013-40

Mucus Relief DM
Guaifenesin 400 mg
Dextromethorphan HBr 20 mg

Expectorant
Cough Suppressant

• Alleviates Chest Congestion

• Reduces Cough

500 Tablets

Immediate Release

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

50844 REV1108B53314 M-17
Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA
Rev. 10/09
Re-order No. 100408

Major 44-533

MUCUS RELIEF DM
dextromethorphan hbr and guiafenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6013
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 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (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:0904-6013-40	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2005	10/31/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/31/2005	10/31/2013

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(0904-6013)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(0904-6013)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(0904-6013)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(0904-6013)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(0904-6013)

Revised: 10/2018

Document Id: 10c146db-ea46-4d24-b5dc-894af9c97b11

Set id: 2217ad78-eaab-49db-a503-45866ad45cdd

Version: 5

Effective Time: 20181016

Major Pharmaceuticals