VANACOF- chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid 
GM Pharmaceuticals, INC

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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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

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
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • 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
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic drinks
  • 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 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 teaspoonfuls in 24 hours.
children under 6 years of age:consult a doctor.

Other information

Inactive ingredients

Citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose

Questions or Comments?

Call 1-888-535-0305 9a.m. – 5p.m. CST

PRINCIPAL DISPLAY PANEL

NDC 58809-999-01
VanaCof ®

Each 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol Hydrochloride ..... 12.5 mg
Dexchlorpheniramine Maleate ......... 1 mg
Pseudoephedrine Hydrochloride ..... 30mg

VanaCof PDP
VanaCof Drug Facts
VANACOF 
chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-999
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-999-0212 in 1 TRAY04/22/2008
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58809-999-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/22/2008
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 8/2023
Document Id: 02e794d3-e6b6-8ee7-e063-6394a90ab69d
Set id: cf3886ab-62b3-497a-a587-18cbfbaf3634
Version: 9
Effective Time: 20230814
 
GM Pharmaceuticals, INC