Guaifenesin 200mg Tablets

Manufacturer: Marlex Pharmaceuticals Inc
Effective date: 2025-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:15:57

Label at a glance#

ProductGuaifenesin 200mg

Active ingredientGUAIFENESIN

Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Dosage and administration

Do not take more than 6 doses in any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

GUAIFENESIN 200 MG TABLETS

MarlexPharmaceuticals, Inc.

----------

Drug Fact

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Guaifenesin 200 mg Tablets

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

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)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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

Do not take more than 6 doses in any 24-hour period.
This product is not intended for use in children under 12 years of age
Adults & children 12 years and over: 1 to 2 tablets every 4 hours
Children under 12 years: do not use

Other Information:

SAFE HANDLING WARNING SECTION

Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

maltodextrin, povidone, silicon dioxide, stearic acid.

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 03/24 AA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0789-01
Guaifenesin
200 mg
100 TABLETS

789-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197741	guaiFENesin 200 MG Oral Tablet	PSN	2
197741	guaifenesin 200 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-789-01	Guaifenesin 200mg	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-789-01	EA - Each	10135-789	601de2dd-3623-460f-9cb3-33bbcb48bb5e	1	2025-05-14

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Guaifenesin 200mg
Guaifenesin
SILICON DIOXIDE
MALTODEXTRIN
POVIDONE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10135-789	10135-789-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
POVIDONE	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GUAIFENESIN	495W7451VQ	ACTIB

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 200mg	GUAIFENESIN	Marlex Pharmaceuticals Inc	13b8f480-d1ac-d70c-e063-6394a90ab4f4	2025-11-13	Warnings	Exact identifier ndc (package): 10135-789-01 ndc (product): 10135-789 ndc11 (package): 10135078901 spl id: 437e388b-2293-0064-e063-6394a90add05 spl set id: 13b8f480-d1ac-d70c-e063-6394a90ab4f4

Reported adverse events (FAERS/openFDA)#

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