Dexbrompheniramine Maleate and Phenylephrine Hydrochloride

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2018-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:25:40

Label at a glance#

ProductDexbrompheniramine Maleate and Phenylephrine Hydrochloride
Active ingredientDEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes 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 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours or as directed by doctor. Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours or as directed by doctor. Children under 6 years of age: Consult a doctor.

Storage and handling

Store at 15º-30ºC (59º-86ºF). Supplied in a tight, light resistant container with a child-resistant cap. Dexbrompheniramine Maleate and Phenylephrine HCl tablets are purple, oval shaped, scored tablets, debossed "WP" bisect "197" on one side and plain on the other.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Dexbrompheniramine Maleate 2 mgAntihistamine
Phenylephrine HCL 10 mgNasal Decongestant

Uses

INDICATIONS & USAGE SECTION

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • 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 enlargment of the prostate gland
  • 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 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
  • symptoms do not improve within 7 days or are accompanied by fever

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 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 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours or as directed by doctor.
Children 6 to under 12 years of age:1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours or as directed by doctor.
Children under 6 years of age:Consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at 15º-30ºC (59º-86ºF). Supplied in a tight, light resistant container with a child-resistant cap. Dexbrompheniramine Maleate and Phenylephrine HCl tablets are purple, oval shaped, scored tablets, debossed "WP" bisect "197" on one side and plain on the other.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, D&C Red #27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide.

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-197-60

Dexbrompheniramine Maleate
and Phenylephrine HCl

Antihistamine • Nasal Decongestant

Each tablet contains:
Dexbrompheniramine Maleate
2 mg
Phenylephrine HCl
10 mg

60 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-197-60EA - Each69367-19700c30068-85ab-46a3-b54c-d5e83085cb1212019-04-11

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
69367-19769367-197-60

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 · Source PDF

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
3cb2fbe4-e0ed-49e2-9668-4c5e8e43791cc174debf-654d-4c07-b697-778f5f411c3d2018-10-26WarningsExact identifier
spl id: 3cb2fbe4-e0ed-49e2-9668-4c5e8e43791c
spl set id: c174debf-654d-4c07-b697-778f5f411c3d

Reported adverse events (FAERS/openFDA)#

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