VANACOF

Dosage form: liquid
Ingredients: Chlophedianol Hydrochloride 12.5mg in 5mL, Dexchlorpheniramine Maleate 1mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: GM Pharmaceuticals
NDC Code: 58809-999

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.

VANACOF

Drug Facts

Active ingredients                             
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Dexchlorpheniramine Maleate 1 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Cough Suppressant
Antihistamine
Nasal Decongestant

Uses

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

  • cough due to minor throat and bronchial irritation
  • 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 a doctor or pharmacist before taking this product

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

Ask a doctor before use if you are

taking sedatives or tranquilizers.

When using this product
  • 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
  • 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

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions Do not exceed recommended dosage.

Adults and children
12 years of age
and over:

2 teaspoonfuls every
6 hours, not to exceed
8 teaspoonfuls in 24
hours.
Children 6 to under
12 years of age:


1 teaspoonful every
6 hours, not to exceed
4 teaspoonful in 24
hours.
Children under 6
years of age
Consult a doctor

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

citric acid, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol, and tutti frutti flavor.

Questions? Comments?

Serious side effects may be reported to this number, call 1-888-535-0305 (8 am to 5 pm).

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 58809-999-01

VANACOF®

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol Hydrochloride..... 12.5 mg
Dexchlorpheniramine Maleate....... 1 mg
Pseudoephedrine Hydrochloride... 30 mg

Cough Suppressant
Antihistamine
Nasal Decongestant
Sugar Free, Alcohol Free,
Dye Free


Tutti Frutti Flavor


16 fl. oz. (473 mL)


GM Pharmaceuticals, Inc.

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

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with a child-resistant cap.

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

Rev. 12/03/13

Patent Pending












VANACOF  
chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-999
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Dexchlorpheniramine Maleate (Dexchlorpheniramine) Dexchlorpheniramine Maleate1 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-999-01473 mL in 1 BOTTLE
2NDC:58809-999-0212 BOTTLE (BOTTLE) in 1 TRAY
215 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/22/2008
Labeler - GM Pharmaceuticals (793000860)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(58809-999)

Revised: 01/2014
 
GM Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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