VANACOF

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

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VANACOF

Drug Facts

Active ingredients                               Purpose
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg..... Cough Suppressant
Dexchlorpheniramine Maleate 1 mg.................. Antihistamine
Pseudoephedrine Hydrochloride 30 mg..... Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of accidental overdose, seek professional help or contact a poison control center immediately.

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 associated with use of this product may be reported to this number.
Call 1-888-535-0305
(8 a.m. to 5 p.m.)

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,
Dyr 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. 10/09


Principal Display Panel and Side Panel for 15 mL Label:

NDC 58809-999-02

VANACOF

Each 5 mL (1 Teaspoonful) Contains:
Chlophedianol HCl....... 12.5 mg
Dexchlorpheniramine Maleate.. 1 mg
Pseudoephedrine HCl............. 30 mg

Cough Suppressant / Antihistamine / Nasal Decongestant

Sugar Free, Alcohol Free, Dye Free


Tutti Frutti Flavor

1/2 fl oz (15 mL)


GM Pharmaceuticals, Inc.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76012

Professional Sample: Not For Sale

Rev. 08/09
Vanacof Packaging

Vanacof Packaging

Vanacof Packaging

Vanacof Packaging

Vanacof Packaging


VANACOF  
chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride   liquid
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)58809-999
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Dexchlorpheniramine Maleate (Dexchlorpheniramine) Dexchlorpheniramine Maleate1 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
158809-999-01473 mL In 1 BOTTLENone
258809-999-0212 BOTTLE In 1 TRAYcontains a BOTTLE
215 mL In 1 BOTTLEThis package is contained within the TRAY (58809-999-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/22/2008

Labeler - GM Pharmaceuticals (793000860)
Revised: 12/2009GM Pharmaceuticals