VAZOBID-PD

Manufacturer
Wraser Pharmaceuticals
Effective date
2011-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:50:00

Label at a glance#

ProductVAZOBID-PD
Active ingredientBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other 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 & over: 3mL every 4-6 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1.5 mL every 4-6 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor

Storage and handling

store at 20°-25°C (68-77°F): F):excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 1 mL) contains:Purpose
Brompheniramine Maleate 1.2 mgAntihistamine
Phenylephrine HCI 2mgDecongestant

Uses:

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other 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 your doctor or pharmacist before taking this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

OTC - DO NOT USE SECTION

Do not take this product if you are taking sedative or tranquilizers, without first consulting your doctor.

OTC - WHEN USING SECTION

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • 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 occurs
  • symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
  • new symptoms occur

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional help or contact a Poison Control Center Immediately. 1-800-222-1222

Directions:

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and children 12 years of age & over: 3mL every 4-6 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1.5 mL every 4-6 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68-77°F): F):excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Inactive ingredients:

INACTIVE INGREDIENT SECTION

acesulfame, artificial bubble gum, aspartame, citric acid, FD&C Red #40, glycerin, methylparaben, neusilin, purified water, sodium benzoate, sodium citrate dehydrate, xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays from 9AM to 4PM CST at 1-888-252-3901 • wraser.com • email: medicalinfo@wraser.com

Distributed by:
WraSer Pharmaceuticals, LLC
Ridgeland, MS 39157

400768 Iss. 011/2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antihistamine • Decongestant

NDC 66992-490-04

VAZOBID-PD™

Brompheniramine Maleate 1.2 mg
Phenylephrine HCI 2 mg

Bubble Gum Flavored Suspension

WraSer PHARMACEUTICALS

Shake Well
4 fl oz (118 mL)

Patent Protected

118 mL Container Label118 mL Container Label


DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66992-490-04ML - Milliliter66992-4905251f039-77a3-4032-918e-ab5c670d0fdd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN032
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FN2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66992-49066992-490-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
9d8b162e-7c39-4b3e-ac26-5548b9329c80aed6d18b-28c1-4571-b641-367a426274b32019-10-31WarningsExact identifier
spl set id: aed6d18b-28c1-4571-b641-367a426274b3

Reported adverse events (FAERS/openFDA)#

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