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Name:Vanacof
Manufacturer:Gm Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


VANACOF

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

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

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)
  • asthma, chronic bronchitis, or emphysema
  • 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. These could be signs 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 to 8 hours, not to
exceed 8 teaspoonfuls
in a 24 hour period
Children 6 to under
12 years of age:
1 teaspoonful every
6 to 8 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period
Children under 6
years of age
Consult a doctor

Other information

Store at 59o-86oF (15o-30oC)

Inactive ingredients

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

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 76012

Rev. 04/11

Patent Pending


VANACOF Packaging


VANACOF Packaging














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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride 12.5 mg  in 5 mL
Dexchlorpheniramine Maleate (Dexchlorpheniramine) Dexchlorpheniramine Maleate 1 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Product Characteristics
Color      Score     
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58809-999-01 473 mL in 1 BOTTLE None
2 NDC:58809-999-02 12 BOTTLE ( BOTTLE) in 1 TRAY contains a BOTTLE
2 15 mL in 1 BOTTLE This package is contained within the TRAY (58809-999-02)

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 (793000860)

Revised: 06/2011 GM Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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