PHARBINEX-DM- guaifenesin 400mg and dextromethorphan hbr 20mg tablet

PHARBINEX-DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Purpose

Expectorant

Cough suppressant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make cough more productive
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a 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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using 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 occure with fever, rash or persistent headache

These could be signs of 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 (1-800-222-1222).

Directions

• take with a full glass of water
• this product can be administered without regard for the timing of meals
• do not exceed 6 doses in 24 hours or as directed by doctor

• adults and children 12 years of age and over:

  take 1 tablet every 4 hours as needed

• children 6 to under 12 years of age:

  take ½ tablet every 4 hours as needed

• children under 6 years of age:

  consult a doctor

Other information

• store at room temperature (15°-30°C)

Inactive ingredients

magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.

Questions?

Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM

PRINCIPAL DISPLAY PANEL

PHARBEST 

NDC: 16103-381-04

Manufactured in the USA

Immediate Release

*Compare to the active ingredient in MUCINEX® DM Tablets

PHARBINEX-DM

Guaifenesin 400mg & Dextromethorphan HBr 20mg

Expectorant & Cough Suppressant

30 TABLETS

INGREDIENTS AND APPEARANCE

PHARBINEX-DM 
guaifenesin 400mg and dextromethorphan hbr 20mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-381
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE (CAPSULE SHAPED TABLET)	Size	18mm
Flavor		Imprint Code	PH073
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16103-381-04	1 in 1 CARTON	04/02/2018
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/02/2018

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(16103-381) , analysis(16103-381) , pack(16103-381) , label(16103-381)