FDA.reportPublic FDA data

Reeses TABtussin

Manufacturer
Reese Pharmaceutical Co | Pharbest
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:54

Label at a glance#

ProductReeses TABtussin
Active ingredientGuaifenesin
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (per tablet

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin  400mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Stop use and ask doctor if

OTC - STOP USE SECTION

  • 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.

If pregnant or breast-feedin

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, stearic acid.

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Distributed By
Reese Pharmaceutical Company
10617 Frank Ave., Cleveland, Ohio 44106 • 1-800-321-7178
www.reesepharmaceutical.com • info@reesepharmaceutical.com

REV 2/21 TABTR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN1
359601guaifenesin 400 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10956-180-242023-01-30C16284748780-1f386c649-fb43-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-180-24Reeses TABtussin2 in 1 CARTONTABLET21
10956-180-24Reeses TABtussin12 in 1 BLISTER PACKTABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-180REESES TABTUSSIN (GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1Legacy NDC, 2 package rows20210312_3c380ced-c4c2-46d0-b548-54fbf04eb666.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10956-18010956-180-24

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
NameUNIIKind
Guaifenesin495W7451VQACTIB
MALTODEXTRIN7CVR7L4A2DIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
COPOVIDONED9C330MD8BIACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONE K30U725QWY32XIACT
POVIDONE K90RDH86HJV5ZIACT

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
7803da73-0ae2-4745-84e5-7cf98374c0f53c380ced-c4c2-46d0-b548-54fbf04eb6662021-03-11WarningsExact identifier
spl id: 7803da73-0ae2-4745-84e5-7cf98374c0f5
spl set id: 3c380ced-c4c2-46d0-b548-54fbf04eb666

Reported adverse events (FAERS/openFDA)#

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