VANACOF description, usages, side effects, indications, overdosage, supplying and lots more!

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VANACOF

GM Pharmaceuticals, Inc.
Pernix Manufacturing, LLC

VANACOF GPE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 15 mL (TBSP))

Chlophedianol HCl 25 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg

Purpose

Cough Suppressant
Expectoran
Nasal Decongestant

VANACOF 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are not 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, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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.  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.
·Use enclosed dosage cup or tablespoon (TBSP).
Adults and children
12 years of age
and over:
15 mL (1 TBSP) every 6 hours,
not to exceed 60 mL (4 TBSP) in
a 24 hour period.
Children 6 to under
12 years of age:

7.5 mL (1/2 TBSP) every 6 hours,
not to exceed 30 mL (2 TBSP) 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

FD&C Red #40, glycerin, maltitol, propylene glycol, purified water, raspberry flavor, sodium saccharin, sorbitol, sucralose.

Questions? Comments?

Call 1-888-535-0305

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 118 mL label:

NDC 58809-624-04

VANACOF® GPE

Each 15 mL (TBSP) contains:
Chlophedianol HCl......................25 mg
Guaifenesin..............................200 mg
Phenylephrine HCl......................10 mg

Cough Suppressant
Expectorant · Nasal Decongestant

Raspberry Flavor

Alcohol Free / Sugar Free
Gluten Free

4 fl. oz. (118 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

Patent Pending                             Iss. 07/12

VANACOF


VANACOF



VANACOF

Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58809-624
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
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
MALTITOL
propylene glycol
water
SACCHARIN SODIUM DIHYDRATE
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58809-624-04 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-09-29


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Be sure to consult your doctor before taking any medication!
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