FDA.reportPublic FDA data

WesTussin DM

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2024-07-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:15:52

Label at a glance#

ProductWesTussin DM
Active ingredientDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itching of the nose of throat itchy, watery eyes temporarily restores freer breathing through the nose

Dosage and administration

Adults 12 and over: 10 mL every 4 hours Not to exceed 60 mL in 24hrs Children 6-12: 5 mL every 4 hours Not to exceed 30 mL in 24hrs Children 2-6: Consult a doctor

Storage and handling

Store at room temperature 15°C-30°C (59°F-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5 mL teaspoonful)Purpose
Dexchlorpheniramine Maleate 1 mgAntihistamine
Dextromethorphan HBr 10 mgCough Suppressant
Phenylephrine HCl 5 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itching of the nose of throat
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompanied by excessive phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • symptoms do not improve within 7 days or are accompanied by fever
  • nervousness, dizziness, or sleeplessness occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 12 and over: 10 mL every 4 hours Not to exceed 60 mL in 24hrs
Children 6-12:5 mL every 4 hours Not to exceed 30 mL in 24hrs
Children 2-6:Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°C-30°C (59°F-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid anhydrous, cotton candy flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

Questions?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 5 PM EST at 1-844-221-7294. You may also report serious side effects to this phone number.

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-334-16

WesTussin DM

Antihistamine • Cough Suppressant
Nasal Decongestant
• Alcohol Free • Dye Free
• Sugar Free • Gluten Free

Each 5 mL (1 teaspoonful) contains:
Dexchlorpheniramine Maleate
1 mg
Dextromethorphan HBr
10 mg
Phenylephrine HCl
5 mg

Cotton Candy Flavor

TAMPER EVIDENT: Tamper evident by foil
seal under cap. Do not use if foil seal is
broken or missing.

16 oz (480 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1990881dexchlorpheniramine maleate 1 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN5
1990881dexchlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD5
1990881dexchlorpheniramine maleate 1 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 mL Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-334-16WesTussin DM480 mL in 1 BOTTLE, PLASTICSYRUP4805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-334WESTUSSIN DM (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [WESTMINSTER PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 1 package rows20240724_68a0cd44-3fdd-430e-af1a-498d4415ab78.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-334-16ML - Milliliter69367-334d0beee12-b102-43df-bac8-a6b368354da712021-09-07

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69367-33469367-334-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXCHLORPHENIRAMINE MALEATEB10YD955QWACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
WesTussin DMDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWestminster Pharmaceuticals, LLC68a0cd44-3fdd-430e-af1a-498d4415ab782024-07-23WarningsExact identifier
ndc (package): 69367-334-16
ndc (product): 69367-334
ndc11 (package): 69367033416
spl id: 465fac60-2904-43f1-8d80-b7b9dc378024
spl set id: 68a0cd44-3fdd-430e-af1a-498d4415ab78

Reported adverse events (FAERS/openFDA)#

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