Mucus Relief DM by Good Sense 345

Drug Details [pdf]

MUCUS RELIEF DM- mucus relief dm tablet
Good Sense

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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345 - Mucus Relief DM

Active ingredient(s)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg.

Purpose

Cough suppressant
Expectorant

Use(s)

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 as may occur with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to 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 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)

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 more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

Pregnancy/Breastfeeding

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 and older: Take 1 caplet 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

do not use if imprinted safety seal under cap is broken or missing
You may report side effects to 1-888-952-0050

Storage

store between 20°-25°C (68°- 77°F)
keep in a dry place and do not expose to heat

Inactive ingredients

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

Questions

Call 1-800-719-9260 Monday through Friday 9AM – 5PM

Principal Display Panel

Mucus Relief DM label

Mucus Relief DM

MUCUS RELIEF DM
mucus relief dm tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-345
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	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AZ345
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 50804-345-30	1 in 1 CARTON	12/23/2014	12/31/2018
1		30 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 - Good Sense (076059836)

Revised: 5/2021

Document Id: 974214d8-469b-417b-ac56-1bf757c976c7

Set id: edc7e38c-4c07-497b-bcc6-80721916d652

Version: 3

Effective Time: 20210506

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