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VANACOF

GM Pharmaceuticals, Inc.

VANACOF G


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Chlophedianol Hydrochloride 25 mg
Guaifenesin 200 mg

Purpose

Cough Suppressant
Expectorant

VANACOF 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


VANACOF 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


VANACOF


VANACOF

Chlophedianol Hydrochloride, Guaifenesin LIQUID

Product Information

Product Type Human otc drug label 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 25 mg
Guaifenesin GUAIFENESIN 200 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58809-571-01 473 in 1 BOTTLE
2 15 in 1 BOTTLE
3 NDC:58809-571-02 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-06


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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