Freds Chest Congestion Relief DM - Reese Pharmaceutical Co | Pharbest

Manufacturer
Reese Pharmaceutical Co | Pharbest
Effective date
2010-07-30
Label type
HUMAN OTC DRUG LABEL
Version
126
Source
full-release
Hydrated at
2026-05-31 22:25:25

Label at a glance#

ProductFreds Chest Congestion Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin
Label structure10 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of cartonEnter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN126
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD126
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY126

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10956-761-012020-01-31C16284748780-19d75b9d0-1402-f424-e053-dadaa90a57cedrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-761-01Freds Chest Congestion ReliefDM1 in 1 CARTONTABLET1126
10956-761-50Freds Chest Congestion ReliefDM50 in 1 BOTTLE, PLASTICTABLET50126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-761FREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]126Legacy NDC, 2 package rows20100803_98e6d6ba-4164-4a14-b186-a5016c7e4c33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10956-761-50EA - Each10956-7610b71f6f4-7473-4c55-bd2a-472905e35bf212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH126
GuaifenesinACTIVE INGREDIENT495W7451VQ126
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS126
GuaifenesinACTIVE MOIETY495W7451VQ126

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10956-76110956-761-50, 10956-761-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7a7843e4-292f-4bcf-8dfb-d0973f3407aa98e6d6ba-4164-4a14-b186-a5016c7e4c332010-07-30Exact identifier
spl id: 7a7843e4-292f-4bcf-8dfb-d0973f3407aa
spl set id: 98e6d6ba-4164-4a14-b186-a5016c7e4c33

Reported adverse events (FAERS/openFDA)#

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