FDA.reportPublic FDA data

WesTussin DM NF

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:17:02

Label at a glance#

ProductWesTussin DM NF
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, DEXBROMPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage Adults and children 12 years of age and over: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours Children under 6 years of age Consult a doctor.

Storage and handling

Store at 59° - 86°F (15° - 30°C)

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
Dexbrompheniramine Maleate 2 mgAntihistamine
Dextromethorphan Hydrobromide 15 mgCough Suppressant
Phenylephrine Hydrochloride 7.5 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

  • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

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

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • new symptoms 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

Do not exceed recommended dosage

Adults and children 12 years of age and over:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours
Children under 6 years of ageConsult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, 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 - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-353-16

WesTussin DM NF

Antihistamine • Cough Suppressant
• Nasal Decongestant
SUGAR FREE / ALCOHOL FREE
DYE FREE / GLUTEN FREE

Each 5 mL (1 teaspoonful) contains:
Dexbrompheniramine Maleate
2 mg
Dextromethorphan HBr
15 mg
Phenylephrine HCl
7.5 mg

Strawberry Flavor

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

16 OZ (473 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1812101dexbrompheniramine maleate 2 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 7.5 MG in 5 mL Oral SolutionPSN3
1812101dexbrompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 3 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD3
1812101dexbrompheniramine maleate 2 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 7.5 MG per 5 ML Oral SolutionSY3

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
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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
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-353-16WesTussin DM NF473 mL in 1 BOTTLELIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-353WESTUSSIN DM NF LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20240810_4e0f9f97-a31c-41ac-9d6c-d81efd20fcef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-353-16ML - Milliliter69367-353acf61788-f756-4ba8-8a13-d0cfafdd9eb512023-09-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69367-35369367-353-16

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
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DEXBROMPHENIRAMINE MALEATEBPA9UT29BSACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

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 DM NFWESTUSSIN DM NFWestminster Pharmaceuticals, LLC4e0f9f97-a31c-41ac-9d6c-d81efd20fcef2024-08-08WarningsExact identifier
ndc (package): 69367-353-16
ndc (product): 69367-353
ndc11 (package): 69367035316
spl id: 820baecb-bfb9-411c-868f-670b81474059
spl set id: 4e0f9f97-a31c-41ac-9d6c-d81efd20fcef

Reported adverse events (FAERS/openFDA)#

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