Dextromethorphan Hydrobromide / Guaifenesin - Reese Pharmaceutical Co | Pharbest

Manufacturer: Reese Pharmaceutical Co | Pharbest
Effective date: 2010-10-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:26:03

Label at a glance#

ProductPremier Value Chest Congestion and cough releif DM

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient - (per tablet) - Purpose

Dextromethorphan Hydrobromide 20mg Cough Suppressant
Guaifenesin 400mg Expectorant

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 (mucous)

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 - DO NOT USE 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 - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions
• Adults and children 12 years of age and over:
take 1 tablet every 4 hours as needed
• Children 610 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 store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

Purpose

Cough Suppressant

Expectorant

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelEnter section text here

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	2
1147685	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet	SCD	2
1147685	guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet	SY	2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10956-020-01	2020-01-31	C162847	48780-1	9d75b9cf-d8ce-f424-e053-dadaa90a57ce	drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10956-020-01	Premier Value Chest Congestion and cough releifDM	1 in 1 CARTON	TABLET	1		2
10956-020-11	Premier Value Chest Congestion and cough releifDM	50 in 1 BOTTLE, PLASTIC	TABLET	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10956-020	PREMIER VALUE CHEST CONGESTION AND COUGH RELEIF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]	2	Legacy NDC, 2 package rows	20101008_a9ab6f06-5857-41ba-a3f6-9290c8e0ec50.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
SILICON DIOXIDE, COLLOIDAL	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2

Products#

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

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

Premier Value Chest Congestion and cough releif DM
Dextromethorphan Hydrobromide / Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
Guaifenesin
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE, COLLOIDAL
COPOVIDONE
MALTODEXTRIN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10956-020	10956-020-11, 10956-020-01

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
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
Guaifenesin	495W7451VQ	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE, COLLOIDAL	ETJ7Z6XBU4	IACT
COPOVIDONE	D9C330MD8B	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 · 173 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 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	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 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, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		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
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 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
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	CAPSULE / ORAL		1346 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	TABLET / SUBLINGUAL		54 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
COPOVIDONE	COPOVIDONE K25-31	D9C330MD8B	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE, COLLOIDAL	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET / ORAL		320 mg	Exact identifier — unii candidate 15 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
0a70b5ed-9dd4-43ab-8064-e4a5770b5d3b			a9ab6f06-5857-41ba-a3f6-9290c8e0ec50	2010-10-04	Warnings	Exact identifier spl id: 0a70b5ed-9dd4-43ab-8064-e4a5770b5d3b spl set id: a9ab6f06-5857-41ba-a3f6-9290c8e0ec50

Reported adverse events (FAERS/openFDA)#

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