Leader Chest Congestion Relief Plus DMDM

Manufacturer: Cardinal Health | Reese Pharmaceutical Co | Pharbest
Effective date: 2012-09-13
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:45:41

Label at a glance#

ProductLeader Chest Congestion Relief Plus DMDM DM

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin

Label structure12 sections

Indications and uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■ Helps make coughs more productive.

Storage and handling

Store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide 20mg

Guaifenesin 400mg

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
■ Helps make coughs more productive.

Warnings

WARNINGS SECTION

Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
■ cough is accompanied by excessive phlegm (mucus)

OTC - STOP USE SECTION

Stop use and ask doctor if
■ symptoms are accompanied by fever, rash or persistent headache
■ cough persists for more than 1 week or tends to recur.
A persistent cough may be a sign of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions
■ Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.
■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed.
■ Children under 6 years of age: consult a doctor.
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of display

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-538-01	2025-04-15	C162847	48780-1	9d75b9d0-df27-f424-e053-dadaa90a57ce	DRUG FACTS
37205-538-71	2025-04-15	C162847	48780-1	9d75b9d0-df27-f424-e053-dadaa90a57ce	DRUG FACTS
37205-538-01	2020-01-31	C162847	48780-1	9d75b9d0-df27-f424-e053-dadaa90a57ce	DRUG FACTS
37205-538-71	2020-01-31	C162847	48780-1	9d75b9d0-df27-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-538-71	EA - Each	37205-538	3a407983-ee3c-4764-aa6f-60cffb04a60c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Leader Chest Congestion Relief Plus DMDM DM
Dextromethorphan Hydrobromide / Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
Guaifenesin
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-538	37205-538-71, 37205-538-01

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
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
Guaifenesin	495W7451VQ	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 157 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	FILM, SOLUBLE / ORAL		19 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates

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
c73cff1b-3980-48b9-9728-9f919394ef08			51b24ef2-ad0e-48cc-974c-2c3a088fd186	2025-04-11	Warnings	Exact identifier spl set id: 51b24ef2-ad0e-48cc-974c-2c3a088fd186

Reported adverse events (FAERS/openFDA)#

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