VANACOF- chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid

VANACOF by

Drug Labeling and Warnings

VANACOF by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

Store at room temperature of 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

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

INGREDIENTS AND APPEARANCE

VANACOF 
chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-999
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 5 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-999-02	12 in 1 TRAY	04/22/2008
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58809-999-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/22/2008

Labeler - GM Pharmaceuticals, INC (793000860)