VANACOF
GM Pharmaceuticals, Inc.
Pernix Manufacturing, LLC
VANACOF GPE
FULL PRESCRIBING INFORMATION: CONTENTS*
- Drug Facts
- VANACOF Uses
- Warnings
- Directions
- VANACOF Other information
- Inactive ingredients
- Questions? Comments?
- Product Packaging
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
VANACOFChlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride LIQUID
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