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VanaCof AC

Medically reviewed on March 31, 2017

Dosage form: liquid
Ingredients: PYRILAMINE MALEATE 25mg in 30mL, CHLOPHEDIANOL HYDROCHLORIDE 12.5mg in 30mL
Labeler: GM Pharmaceuticals, Inc.
NDC Code: 58809-329

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 AC

Active Ingredients

Each 30 mL contains:

Chlophedianol HCl ...........12.5

Pyrilamine Maleate ...........25

Purpose

Cough Suppressant

Antihistamine

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
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not exceed recommended dosage

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis

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

When using this poduct

  • do not use more than directed
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholics drinks
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if:
  • nervousness, dizziness or sleeplessnss occurs
  • symptoms do not improve within 7 days, tend to recur, 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 professhional 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 take more than 4 doses in any 24-hour period.
  • Do not exceed recommended dosage.
  • Use enclosed dose cup
  • Keep dosage cup with product

adults and children 12 years of age and over:

60 mL every 6-8 hours

children 6 to under 12 years of age:3030 mLevery 6-8 hours
children under 6 years of age:Do not use

Other information
  • each 30 mL contains: Sodium 12 mg
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • store at room temperature 68-77ºF (20-25ºC)
  • avoid excessive heat and humidity

Inactive Ingredients

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

Questions or Comments?

Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

Distributed by:

GM Pharmaceuticals

Arlington, TX 76015

VANACOF AC 
chlophedianol hcl, pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-329
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE25 mg  in 30 mL
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
WATER 
SODIUM BENZOATE 
SUCRALOSE 
TRISODIUM CITRATE DIHYDRATE 
SORBITOL 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:58809-329-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2017
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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