Guaifenesin DM

Manufacturer: PD-Rx Pharmaceuticals, Inc.
Effective date: 2023-10-02
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-05-31 23:56:23

Label at a glance#

ProductGuaifenesin 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 (59°-86°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at room temperature 15°-30°C (59°-86°F)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

43063801 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	9
1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD	9
1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY	9

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
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	SPL version
43063-801-30	Guaifenesin DM	30 in 1 BOTTLE, PLASTIC	TABLET	30	9
43063-801-60	Guaifenesin DM	60 in 1 BOTTLE, PLASTIC	TABLET	60	9
43063-801-90	Guaifenesin DM	90 in 1 BOTTLE, PLASTIC	TABLET	90	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-801	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20231003_ac8c0c15-b305-47f2-8712-e4b53636f7fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-801-30	EA - Each	43063-801	3c014083-7e0c-4bf5-8cde-bdbfddb3add1	1	2023-03-13
43063-801-60	EA - Each	43063-801	d83d21cb-25be-4d0a-b0e1-2787c8e4d0c9	1	2018-01-12
43063-801-90	EA - Each	43063-801	0f54a697-5994-450c-abb2-d643ac2833f3	1	2018-01-12
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.

Guaifenesin DM
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43063-801	43063-801-90, 43063-801-60, 43063-801-30
16103-381

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
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	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 · 2 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 (product): 16103-381
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	ac8c0c15-b305-47f2-8712-e4b53636f7fa	2023-10-02	Warnings	Exact identifier ndc (package): 43063-801-90 ndc (package): 43063-801-30 ndc (package): 43063-801-60 ndc (product): 43063-801 ndc11 (package): 43063080160 ndc11 (package): 43063080130 ndc11 (package): 43063080190 spl id: 06c3176d-e6f9-4231-e063-6394a90a694b spl set id: ac8c0c15-b305-47f2-8712-e4b53636f7fa

Reported adverse events (FAERS/openFDA)#

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