FDA.reportPublic FDA data

Pyrilamine Maleate and Dextromethorphan Hydrobromide

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2024-08-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:18:02

Label at a glance#

ProductPyrilamine Maleate and Dextromethorphan Hydrobromide
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PYRILAMINE MALEATE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation associated with a cold alleviates cough to help you sleep nonnarcotic cough suppressant for the relief of cough

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor Children under 6 years of age: 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 ingredient (in each 5 mL teaspoonful)Purpose
Dextromethorphan HBr 7.5 mgAntitussive
Pyrilamine Maleate 7.5 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation associated with a cold
  • alleviates cough to help you sleep
  • nonnarcotic cough suppressant for the relief of cough

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

  • a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

OTC - DO NOT USE SECTION

Do not use this product

  • 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
  • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age and over:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age: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

Anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69367-398-16

Pyrilamine Maleate
and
Dextromethorphan HBr
Liquid

Antitussive • Antihistamine

Sugar Free • Alcohol Free
• Dye Free • Gluten Free

Each teaspoonful (5 mL) for oral
administration contains:

Dextromethorphan HBr
7.5 mg

Pyrilamine Maleate
7.5 mg

Candy Apple Flavor

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

Supplied in a tight container with a
child-resistant cap.

16oz. (473mL)

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
1423307dextromethorphan HBr 7.5 MG / pyrilamine maleate 7.5 MG in 5 mL Oral SolutionPSN2
1423307dextromethorphan hydrobromide 1.5 MG/ML / pyrilamine maleate 1.5 MG/ML Oral SolutionSCD2
1423307dextromethorphan hydrobromide 7.5 MG / pyrilamine maleate 7.5 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-398-16Pyrilamine Maleate and Dextromethorphan Hydrobromide473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-398PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240829_dd068449-9d24-41e6-8a6e-f69c9fe263f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-398-16ML - Milliliter69367-3986c526e72-5e66-4165-ac3f-9c5460d3c00a12024-08-12

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69367-39869367-398-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
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
Pyrilamine Maleate and Dextromethorphan HydrobromidePYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWestminster Pharmaceuticals, LLCdd068449-9d24-41e6-8a6e-f69c9fe263f22024-08-26WarningsExact identifier
ndc (package): 69367-398-16
ndc (product): 69367-398
ndc11 (package): 69367039816
spl id: c0f27c81-43c1-4e63-b3a4-ccbd15f35ab4
spl set id: dd068449-9d24-41e6-8a6e-f69c9fe263f2

Reported adverse events (FAERS/openFDA)#

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