VAZOBID-PD by Wraser Pharmaceuticals VAZOBID-PD

VAZOBID-PD by

Drug Labeling and Warnings

VAZOBID-PD by is a Otc medication manufactured, distributed, or labeled by Wraser Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VAZOBID-PD- brompheniramine maleate and phenylephrine hydrochloride liquid 
Wraser LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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VAZOBID-PD

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

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.

Warnings:

Do not exceed recommended dosage

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 your doctor or pharmacist before taking this product

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

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

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

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
  • new symptoms occur

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

Keep out of reach of children.

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

Directions:

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

  • 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:

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?

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

Distributed by:
WraSer Pharmaceuticals, LLC
Ridgeland, MS 39157

400768 Iss. 011/2011

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 Label


VAZOBID-PD 
brompheniramine maleate and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66992-490
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1.2 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME (UNII: MA3UYZ6K1H)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM ALUMINOMETASILICATE TYPE IA (UNII: 7LVU907546)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66992-490-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/201107/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/201107/31/2019
Labeler - Wraser LLC (121828334)

Revised: 10/2019
 
Wraser LLC