TopCare Tab Tussin DM - TOPCO ASSOCIATES LLC | Reese Pharmaceutical Co

Manufacturer
TOPCO ASSOCIATES LLC | Reese Pharmaceutical Co
Effective date
2021-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:12

Label at a glance#

ProductTopCare Tab Tussin 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

OTC - ASK DOCTOR SECTION

If you have 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

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.

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 Center immediately

Pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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

Warning

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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN2
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD2
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY2

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
36800-442-242023-01-30C16284748780-1f386c649-9ca1-0266-e053-dadaa90a7c1aDrug Facts TOPCARE Tab Tussin DM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-442-24TopCare Tab TussinDM2 in 1 CARTONTABLET22
36800-442-24TopCare Tab TussinDM12 in 1 BLISTER PACKTABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-442TOPCARE TAB TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [TOPCO ASSOCIATES LLC]2Legacy NDC, 2 package rows20210507_89df0de0-cc40-4e0e-bad0-5eb66e187471.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-44236800-442-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
aef89742-077f-4504-a26a-c3d546cefd5f89df0de0-cc40-4e0e-bad0-5eb66e1874712021-05-06WarningsExact identifier
spl id: aef89742-077f-4504-a26a-c3d546cefd5f
spl set id: 89df0de0-cc40-4e0e-bad0-5eb66e187471

Reported adverse events (FAERS/openFDA)#

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