GUAIFENESIN DM - guaifenesin and dextromethorphan hydrobromide tablet, extended release
Physicians Total Care, Inc.

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Drug Facts

Active ingredients (in each extended-release bi-layer tablet)	Purpose
Dextromethorphan HBr 60 mg	Cough suppressant
Guaifenesin 1200 mg	Expectorant

Uses

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

for children under 12 years of age
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 crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age: do not use

Other information

tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
store at 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

Relabeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL

Guaifenesin DM Tablets

1200 mg guaifenesin
60 mg dextromethorphan HBr

GUAIFENESIN DM
guaifenesin and dextromethorphan hydrobromide tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-5134(NDC:63824-072)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (Guaifenesin)	Guaifenesin	1200 mg
Dextromethorphan Hydrobromide (Dextromethorphan)	Dextromethorphan Hydrobromide	60 mg

Inactive Ingredients
Ingredient Name	Strength
magnesium stearate
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	WHITE (yellow and white)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	Mucinex;1200
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54868-5134-0	30 TABLET, EXTENDED RELEASE ( TABLET) in 1 BOTTLE	None
2	NDC:54868-5134-1	20 TABLET, EXTENDED RELEASE ( TABLET) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021620	12/17/2004	11/15/2007

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 03/2012 Physicians Total Care, Inc.