Pharbinex DM Tablet

Manufacturer: Pharbest Pharmaceuticals, Inc.
Effective date: 2025-12-24
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:28:34

Label at a glance#

ProductPHARBINEX-DM

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE

Label structure8 sections

Indications and 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

Storage and handling

store at room temperature (15°-30°C) Tamper Evident: do not use if safety seal under cap is broken or missing

Contacts and useful links#

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take with a full glass of water
do not exceed 6 doses in 24 hours

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

STORAGE AND HANDLING SECTION

store at room temperature (15°-30°C)
Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-381-04

Manufactured in the USA

Immediate Release

PHARBINEX-DM

*Compare to the active ingredient in MUCINEX^® DM Tablets

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Expectorant &

Cough Suppressant

30 TABLETS

Pharbinex DM Tablet Product Label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1147685	Dextromethorphan/guaiFENesin (Oral Pill)	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1147685	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet	PSN	3
1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD	3
1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-381-04	2024-01-19	C162847	48780-1	d6a99b39-5008-a426-e053-dadaa90af4c2	Pharbinex DM Tablet
16103-381-04	2022-01-28	C162847	48780-1	d6a99b39-5008-a426-e053-dadaa90af4c2	Pharbinex DM Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-381-04	PHARBINEX-DM	30 in 1 BOTTLE, PLASTIC	TABLET	30		3
16103-381-04	PHARBINEX-DM	1 in 1 CARTON	TABLET	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-381-04	EA - Each	16103-381	664835dc-933a-4b91-ac8b-a266b1b26c66	1	2023-03-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

PHARBINEX-DM
GUAIFENESIN 400mg and DEXTROMETHORPHAN HBR 20MG
GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16103-381	16103-381-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHARBINEX-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Pharbest Pharmaceuticals, Inc.	8d71db43-da87-45ee-aa4a-7e870bc5016d	2025-12-24	Warnings	Exact identifier ndc (package): 16103-381-04 ndc (product): 16103-381 ndc11 (package): 16103038104 spl id: fcbabd90-abc6-4a05-8841-58cb74b5a22e spl set id: 8d71db43-da87-45ee-aa4a-7e870bc5016d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.