GUAIFENESIN

Manufacturer: Pharbest Pharmaceuticals, Inc.
Effective date: 2025-12-24
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:28:33

Label at a glance#

ProductGUAIFENESIN

Active ingredientGUAIFENESIN

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

Storage and handling

store at room temperature (15°-30°C) T amper 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 Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

Purpose

OTC - PURPOSE SECTION

Expectorant

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

Warnings

WARNINGS SECTION

Ask 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)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of serious illness.

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 cellulose, 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 16103-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*COMPARE TO the active ingredient in MUCINEX^® Tablets

Guaifenesin 400mg

Expectorant

30 TABLETS

Pharbinex Tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	2
359601	guaifenesin 400 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-379-04	2025-12-25	C162847	48780-1	f386c64a-18e4-0266-e053-dadaa90a7c1a	Drug Facts
16103-379-04	2023-01-30	C162847	48780-1	f386c64a-18e4-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-379-04	GUAIFENESIN	1 in 1 CARTON	TABLET	1		2
16103-379-04	GUAIFENESIN	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

GUAIFENESIN
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16103-379	16103-379-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GUAIFENESIN	495W7451VQ	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
GUAIFENESIN	GUAIFENESIN	Pharbest Pharmaceuticals, Inc.	0bf70fb4-d3c8-476d-b864-4eadc697a7d8	2025-12-24	Warnings	Exact identifier ndc (package): 16103-379-04 ndc (product): 16103-379 ndc11 (package): 16103037904 spl id: 3038393b-2c7b-4f5d-8b5d-d6054f663336 spl set id: 0bf70fb4-d3c8-476d-b864-4eadc697a7d8

Reported adverse events (FAERS/openFDA)#

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