GUAIFENESIN DM- guaifenesin and dextromethorphan hydrobromide tablet

Guaifenesin DM by

Drug Labeling and Warnings

Guaifenesin DM by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient Section

Active ingredients (per tablet) Purpose

Guaifenesin 400 mg Expectorant

Dextromethorphan HBr 20 mg Cough suppressant

Keep Out Of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately (800)222-1222

Indications & Usage

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Helps make coughs more productive.

These highlights do not include all the information needed to use Guaifenesin DM, See full prescribing information for Guaifenesin DM Initial U.S. Approval 04/29/2004

Warnings

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.

Ask a doctor before use if

• Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema
• Cough accompanied by excessive phegm (mucus)

Stop Use Section

Stop use and ask a doctor if

• Symptons are accompanied by fever, rash or persistent headache
• cough persists for more than 1 week or tends to recur
• A persistent cough may be a sign of a serious sondition

Pregnancy or breast feeding

If pregnant or breastfeeding ask a health professional befoe use.

Questions?

Questions? Adverse drug event call : (866) 562-2756

Storage

• Other Informtion
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredient

Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Purpose

Active Ingredient Purpose

Guaifenesin 400mg.............................Expectorant

Dextromethorphan HBr 20mg.............Cough Suppressant

DOSAGE & ADMINISTRATION

Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours as needed with a full glass of water while symptoms persist.

Do not exceed 6 doses in 24 hours.

Children 6 to 12 years of age take 1/2 tablet every 4 hours as needed with a full glass of water.

Children under 6 years of age consult a doctor.

These highlights do not include all the information needed to use Guaifenesin DM

See full prescribing information for Guaifenesin DM

Initial U.S. Approval 04/29/04

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN DM 
guaifenesin and dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43063-801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	PH;073
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43063-801-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017	11/30/2027
2	NDC: 43063-801-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017	11/30/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/14/2017	11/30/2027

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(43063-801)