MUCUS RELIEF DM- dextromehtorphan hbr / guaifenesin tablet
Chain Drug Consortium

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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Drug Facts

Active ingredient

Guaifenesin 400mg

Dextromehtorphan HBr 20mg

Purposes

Expectorant

Cough Suppressant

Uses

helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold

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 Doctor before use if you have

Ask Doctor/Pharmacist before use if you are

taking sedatives or tranquilizers

When Using this product

■do not exceed recommended dosage

■ do not use for more than 7 days

Stop Use and ask a doctor if

■ cough lasts for more than 7 days, recurs, or is accompanied by 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use

Inactive Ingredients

colloidal silicon dioxide*, croscarmellose sodium*, magnesium stearate*, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate*, stearic acid.

Package/Label Principal Display Panel

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MUCUS RELIEF DM
dextromehtorphan hbr / guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-179
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AZ345
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-179-50	50 in 1 BOX; Type 0: Not a Combination Product	11/05/2014	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/05/2014	10/01/2018

Labeler - Chain Drug Consortium (101668460)

Registrant - Chain Drug Consortium (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	manufacture(68016-179) , pack(68016-179) , label(68016-179) , relabel(68016-179) , repack(68016-179)

Revised: 10/2018

Document Id: 78d82a9d-9a4b-278b-e053-2991aa0a62e0

Set id: ddca884a-a2b7-42f8-bef9-1d528632b876

Version: 2

Effective Time: 20181022

Chain Drug Consortium