PHARBINEX-DM

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg
Labeler: Pharbest Pharmaceuticals, Inc.
NDC code: 16103-381

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Drug Facts

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

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

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID

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

Packaging
#	Item Code	Package Description
1	NDC:16103-381-04	1 BOTTLE, PLASTIC in 1 CARTON
1		30 TABLET in 1 BOTTLE, PLASTIC

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	Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(16103-381), analysis(16103-381), pack(16103-381), label(16103-381)

Document Id: 7cf187b4-776b-4cc5-8416-9757210cb423

Set id: 8d71db43-da87-45ee-aa4a-7e870bc5016d

Version: 1

Effective Time: 20180402

Pharbest Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer