MUCUS RELIEF DM IMMEDIATE RELEASE- dextromethorphan hbr and guaifenesin tablet
Allegiant Health

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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Sound Body Mucus Relief DM

Active ingredient (in each tablet)

Dextromethorphan HBr 20mg
Guaifenesin 400mg

Purpose

Cough Suppressant

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways and make coughs more productive

temporarily relieves:
cough due to minor sore throat and bronchial irritation as may occur with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you sleep

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 am 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)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

do not use more than directed

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness

If you are 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 (1-800-222-1222) 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

Other information

store at 25ºC (77ºF) excursions between 15º-30ºC (59º-86ºF)
keep in a dry place and do not expose to heat
do not use if imprinted safety seal under cap is broken or missing
You may report side effects to 1-888-952-0500.

Inactive ingredients

croscarmellose sodium, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Principal Display Panel

Mucus Relief DM

MUCUS RELIEF DM IMMEDIATE RELEASE
dextromethorphan hbr and guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-543
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)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	AZ345
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69168-543-26	1 in 1 CARTON	12/23/2014	12/31/2018
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69168-543-60	1 in 1 CARTON	12/23/2014	12/31/2018
2		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/23/2014	12/31/2018

Labeler - Allegiant Health (079501930)

Revised: 12/2018

Document Id: c5d5fcc0-5008-421f-97fd-6db726475eab

Set id: 99fc1c8b-5dd9-4c24-b866-7f776dfb2d84

Version: 4

Effective Time: 20181210

Allegiant Health