Reeses TABtussin DM - Reese Pharmaceutical Co

Manufacturer
Reese Pharmaceutical Co
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:55

Label at a glance#

ProductReeses TABtussin 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

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active ingredient - (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

cough is accompanied by excessive phlegm (mucous)

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

Do not use

OTC - DO NOT USE SECTION

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In  ase of overdose, get medical help or contact a Poison Center immediately

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

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

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

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.

Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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

REV 3/21 TDMTR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN1
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD1
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY1

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
10956-161-242023-01-30C16284748780-1f386c64a-4a24-0266-e053-dadaa90a7c1aReese's TABtussin DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-161-24Reeses TABtussinDM12 in 1 BLISTER PACKTABLET121
10956-161-24Reeses TABtussinDM2 in 1 CARTONTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-161REESES TABTUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]1Legacy NDC, 2 package rows20210312_92ca7aa7-6dc0-4a3b-98bc-1111740463c6.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10956-16110956-161-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
bc5bf4a2-ec2f-46f8-9d5c-ddcceb2f17e192ca7aa7-6dc0-4a3b-98bc-1111740463c62021-03-11WarningsExact identifier
spl id: bc5bf4a2-ec2f-46f8-9d5c-ddcceb2f17e1
spl set id: 92ca7aa7-6dc0-4a3b-98bc-1111740463c6

Reported adverse events (FAERS/openFDA)#

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