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VANACOF-8

Medically reviewed by Drugs.com. Last updated on Sep 3, 2018.

Dosage form: liquid
Ingredients: CHLOPHEDIANOL HYDROCHLORIDE 25mg in 15mL, PYRILAMINE MALEATE 50mg in 15mL
Labeler: GM PHARMACEUTICALS,INC
NDC Code: 58809-350

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®-8

Drug Facts

Active ingredients (in each 15 mL (TBSP))Purpose
Chlophedianol HCl 25 mgCough Suppressant
Pyrilamine Maleate 50 mgAntihistamine

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

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

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

When using this product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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 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.
  • Use enclosed dosage cup or tablespoon (TBSP).
Adults and children 12 years of age and over:15 mL (1 TBSP) every 6 to 8 hours, not to exceed 60 mL (4 TBSP) in a 24 hour period.
Children 6 to under 12 years of age:7.5 mL (½ TBSP) every 6 to 8 hours, not to exceed 30 mL (2 TBSP) in a 24 hour period.
Children under 6 years of age:Consult a doctor.

Other information
  • Each 15 mL (TBSP) contains: Sodium 7 mg.
  • Store at 59° to 86°F (15° to 30°C).

Inactive ingredients

Glycerin, Green Apple Flavor, Maltitol, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol, Sucralose.

Questions? Comments?

Call 1-888-535-0305

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 58809-350-04
VANACOF®- 8

Cough
Runny Nose / Sneezing

Each 15 mL (TBSP) contains:
Chlophedianol HCl 25 mg
Pyrilamine Maleate 50 mg

Cough Suppressant • Antihistamine

Green Apple Flavor

Alcohol Free / Sugar Free / Gluten Free
Decongestant Free

4 fl. oz. (118 mL)

VANACOF-8 
chlophedianol hydrochloride and pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-350
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE25 mg  in 15 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE50 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLE (Green Apple) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-350-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2013
Labeler - GM PHARMACEUTICALS,INC (793000860)

 
GM PHARMACEUTICALS,INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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