MUCUS RELIEF DM- dextromethorphan hydrobromide and guaifenesin tablet, coated
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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 ingredients (in each tablet)

Dextromethorphan HBr 20 mg*

Guaifenesin 400 mg**

Purpose

*Cough suppressant

**Expectorant

Uses

helps loosen phlegm (mucus)
helps thin bronchial secretions to make coughs more productive
temporarily relieves cough due to minor 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 a doctor before use if you have

cough accompanied with excessive 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
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 with fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children

If pregnant or breast-feeding, ask a health care 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

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

each tablet contains: sodium 20 mg LOW SODIUM
store at
controlled room temperature 15°-30°C (59°-86°F)
keep in a dry place and do not expose to excessive heat
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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

Package/Label Principal Display Panel

NDC 63548-6352-*1

IMMEDIATE ACTING

MUCUS RELIEF DM

EXPECTORANT/COUGH SUPPRESSANT

400 mg Guaifenesin and

20 mg Dextromethorphan HBr

Loosens Congestion

Soothes Cough

30 TABLETS

MUCUS RELIEF DM
dextromethorphan hydrobromide and guaifenesin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63548-6352
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	6mm
Flavor		Imprint Code	G2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63548-6352-1	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2010	02/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	01/02/2010	02/28/2017

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017

Document Id: 88b54df6-9e48-4857-b54a-d748de7eb1ef

Set id: 9ea81f82-8fee-4569-8cfc-a102a9747de0

Version: 2

Effective Time: 20170330

PLD Acquisitions LLC DBA Avéma Pharma Solutions