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Name:Vanacofg
Manufacturer:Gm Pharmaceuticals, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


VANACOF G

VANACOF G - chlophedianol hydrochloride and guaifenesin 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 G

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 25 mg
Guaifenesin 200 mg

Purpose

Cough Suppressant
Expectorant

Uses

temporarily relieves these symptoms due to the common cold:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

  • cough 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 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:

1 teaspoonful every
6 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period
Children 6 to under
12 years of age:


1/2 teaspoonful every
6 hours, not to
exceed 2 teaspoonfuls
in a 24 hour period
Children under 6
years of age
Consult a doctor


Other information

Store at 59°- 86°F (15°- 30°C)

Inactive ingredients

Berry Vanilla Flavor, Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, and Sucralose.

Questions? Comments?

Call 1-888-535-0305

Product Packaging

The packaging below represents labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 58809-571-01

VANACOF G

EACH 5 mL (1 TEASPOONFUL) CONTAINS:


Chlophedianol Hydrochloride........................25 mg
Guaifenesin..............................................200 mg

Cough Suppressant / Expectorant

Alcohol Free / Gluten Free
Sugar Free / Dye Free

Berry Vanilla 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

Patent Pending

Rev. 04/11

VANACOF G Packaging


VANACOF G Packaging



VANACOF  G
chlophedianol hydrochloride, guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-571
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride 25 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 200 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Citric Acid  
Glycerin  
Propylene Glycol  
Water  
Sodium Citrate  
Saccharin Sodium  
Sorbitol  
Sucralose  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY, VANILLA Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58809-571-01 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/06/2011

Labeler - GM Pharmaceuticals, Inc. (793000860)

Revised: 06/2011 GM Pharmaceuticals, Inc.



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


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