Mission Pharmacal Introduces Two New Cough and Cold Medications

Hycofenix™ offers the first and only FDA-approved combination of hydrocodone, pseudoephedrine, and guaifenesin, delivering three major benefits to patients in one prescription.

19 Nov, 2015, 12:06 ET from Mission Pharmacal Company

SAN ANTONIO, Nov. 19, 2015 /PRNewswire/ -- The Cough and Cold season is coming on strong. Relief options are here! Mission Pharmacal Company recently announced the national product launch of Hycofenix™ (hydrocodone bitartrate, pseudoephedrine hydrochloride, and guaifenesin) Oral Solution. Hycofenix effectively relieves three cough and cold symptoms in just one prescription. Mission has also announced the launch of Flowtuss™ (hydrocodone bitartrate and guaifenesin) Oral Solution. The combination of clinically proven ingredients in Flowtuss offers relief of two cough and cold symptoms in just one prescription.

Hycofenix is the first and only combination of hydrocodone, pseudoephedrine, and guaifenesin approved by the U.S. Food and Drug Administration (FDA). These three clinically proven ingredients provide triple action and targeted relief from symptoms associated with the common cold.

"Mission Pharmacal is pleased to offer multi-action Hycofenix and Flowtuss to the medical community to fulfill an unmet healthcare need in the cough and cold therapeutic area," says Ron Scalf, Vice President, Pharmaceutical Sales, Mission Pharmacal. "In just one prescription, Hycofenix effectively relieves the cough, loosens respiratory secretions for a more productive cough, and clears nasal congestion. For the patient that does not need the nasal decongestant, Flowtuss effectively relieves the cough and loosens respiratory secretions for a more productive cough."

Both products are available in black raspberry flavor and have been approved by the FDA for use in patients 18 years of age and older.

In preparation for this launch, Mission has expanded its sales force and increased promotional efforts to reach more Primary Care and Internal Medicine healthcare providers across the United States. All team members have completed extensive training related to cough and cold therapeutic needs, as well as pharmacy stocking and administrative needs for products containing hydrocodone, which is classified as a Schedule II, narcotic based, anti-tussive.

"To support customer needs related to Hycofenix and Flowtuss, we have nearly doubled the size of our sales team," says John McLaughlin, Sales Director, Primary Care Division, Mission Pharmacal. "We are excited that the addition of these products in a new therapeutic class enables us to grow and better serve primary care providers and their patients."

Mission has invested in many programs that will help patients quickly obtain Hycofenix or Flowtuss at an affordable price. Through partnerships, Mission provides value-added programs to healthcare providers, pharmacies, and patients. These include retail partner pharmacy stocking support, coupons and discounts, and email notifications about product availability.

"Based on initial market research and evaluation, we learned that healthcare providers are very interested in products that contain an expectorant in their combination therapy. Both of our products contain guaifenesin, an expectorant to help loosen respiratory secretions for a more productive cough," says Dawn Garvin, Product Manager for Hycofenix and Flowtuss, Mission Pharmacal. "We are excited to introduce these two products that will offer relief for patients that suffer from specific symptoms during the cough and cold season."

To learn more about Mission Pharmacal Company and its products, visit missionpharmacal.com.

INDICATIONS: HYCOFENIX™ oral solution is a prescription medicine used to treat cough and stuffy nose, and to loosen mucus associated with the common cold. HYCOFENIX is for adults and should not be used in children under 18 years of age. HYCOFENIX contains three medicines, hydrocodone (a narcotic cough suppressant), pseudoephedrine (for stuffy nose), and guaifenesin (to loosen mucus).

Important Safety Information
HYCOFENIX is a controlled substance (CII) because it contains hydrocodone that can be abused by certain people. HYCOFENIX can produce drug dependence. Keep your HYCOFENIX in a safe place to protect it from theft. Never give your HYCOFENIX to anyone else, because it may harm them or cause death. Selling or giving this medicine away is against the law.

HYCOFENIX is not for everyone. You should not take HYCOFENIX if you are allergic to hydrocodone, pseudoephedrine, guaifenesin, or any of the inactive ingredients in HYCOFENIX, or if you are taking a monoamine oxidase inhibitor (MAOI) for depression or other conditions, and for 14 days after discontinuing your MAOI. You should also not take HYCOFENIX if you have glaucoma, trouble urinating (urinary retention), severe high blood pressure, or severe coronary artery disease.

HYCOFENIX should not be used in children under six years of age because it may cause a decreased rate of breathing (respiratory depression) which can lead to death.

Before you take HYCOFENIX, tell your doctor if you have heart disease or high blood pressure, lung or breathing problems and/or a persistent cough, have had a head injury, have pain in your belly, have prostate problems, have problems with your urinary tract (urinary strictures), use alcohol, have liver or kidney problems, have thyroid problems such as hypothyroidism, or have Addison's disease (low cortisol). Do not take HYCOFENIX if you are pregnant, or may become pregnant. Regular use of HYCOFENIX before your baby is born may cause your newborn baby to have withdrawal symptoms or serious breathing problems which can lead to death. Some drugs can pass to infants through breast milk, and there may be serious side effects from HYCOFENIX, so you should stop nursing or discontinue the medicine if you wish to breastfeed.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not take other prescription drugs or over-the-counter medications while you are taking HYCOFENIX unless you are directed to do so by your  doctor. In particular, tell your doctor if you are taking any pain medicines such as narcotics, cold or allergy medicines that contain cough suppressants or antihistamines, medicines for mental illness (antipsychotics, anti-anxiety), drink alcohol, take medicines for depression including MAOIs or tricyclic antidepressants, take medicines for stomach or intestinal problems.

You must take HYCOFENIX exactly as prescribed by your physician. Ask your pharmacist to give you a measuring device to help you measure the correct amount of HYCOFENIX. Do not use a household teaspoon as you may accidentally take too much.

HYCOFENIX can cause you to be drowsy so do not drive or use machinery. Do not drink alcohol while taking HYCOFENIX as it can cause serious side effects.

HYCOFENIX can cause serious side effects in some people including decreased breathing which can lead to death, drowsiness which can prevent you from thinking clearly or can cause an accident, pounding heartbeats or fluttering in your chest, abnormal heart rhythm, bowel problems including bowel obstruction, sleeplessness, dizziness, weakness, shakiness, convulsions, increased blood   pressure, and failure of your circulation with serious low blood pressure.

The most common side effects of HYCOFENIX are: dizziness, headache, drowsiness, nausea, diarrhea, flushing, and decreased blood pressure.

Always tell your doctor about any side effects that bother you or do not go away.

To report negative side effects, contact Mission Pharmacal Company at 1-8002981087 or the FDA at 1800FDA1088 or www.fda.gov/medwatch.

Please see hycofenix.com for full Prescribing Information.

INDICATIONS: FLOWTUSS™ oral solution is a prescription medicine used to treat cough and to loosen mucus associated with the common cold. FLOWTUSS is for adults and should not be used in children under 18 years of age. FLOWTUSS contains two medicines, hydrocodone (a narcotic cough suppressant) and guaifenesin (to loosen mucus).

Important Safety Information
FLOWTUSS is a controlled substance (CII) because it contains hydrocodone that can be abused by certain people. FLOWTUSS can produce drug dependence. Keep your FLOWTUSS in a safe place to protect it from theft. Never give your FLOWTUSS to anyone else, because it may harm them or cause death. Selling or giving this medicine away is against the law.

FLOWTUSS is not for everyone. You should not take FLOWTUSS if you are allergic to hydrocodone, guaifenesin, or any of the inactive ingredients in FLOWTUSS, or if you are taking a monoamine oxidase inhibitor (MAOI) for depression or other conditions, and for 14 days after discontinuing your MAOI.

FLOWTUSS should not be used in children under six years of age because it may cause a decreased rate of breathing (respiratory depression ) which can lead to death.

Before you take FLOWTUSS, tell your doctor if you have lung or breathing problems and/or a persistent cough, have had a head injury, have pain in your belly, have prostate problems, have problems with your urinary tract (urinary strictures), use alcohol, have liver or kidney problems, have diabetes, have thyroid problems such as hypothyroidism, or have Addison's disease (low cortisol). Do not take FLOWTUSS if you are pregnant or may become pregnant. Regular use of FLOWTUSS before your baby is born may cause your newborn baby to have withdrawal symptoms or serious breathing problems which can lead to death. Some drugs can pass to infants through breast milk, and there may be serious side effects from FLOWTUSS, so you should stop nursing or discontinue the medicine if you wish to breastfeed.

Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not take other prescription drugs or over-the-counter medications while you are taking FLOWTUSS unless you are directed to do so by your doctor. In particular, tell your doctor if you are taking any pain medicines such as narcotics cold or allergy medicines that contain cough suppressants or antihistamines, medicines for mental illness (antipsychotics, anti-anxiety), drink alcohol, take medicines for depression including MAOIs or tricyclic antidepressants, take medicines for stomach or intestinal problems.

You must take FLOWTUSS exactly as prescribed by your physician. Ask your pharmacist to give you a measuring device to help you measure the correct amount of FLOWTUSS. Do not use a household teaspoon as you may accidentally take too much.

FLOWTUSS can cause you to be drowsy so do not drive or use machinery. Do not drink alcohol while taking FLOWTUSS as it can cause serious side effects.

FLOWTUSS can cause serious side effects in some people including decreased breathing which can lead to death, drowsiness which can prevent you from thinking clearly or can cause an accident, and bowel problems including bowel obstruction.

The most common side effects of FLOWTUSS are: dizziness, headache, drowsiness, nausea, diarrhea, flushing, and decreased blood pressure.

Always tell your doctor about any side effects that bother you or do not go away.

To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see flowtuss.com for full Prescribing Information.

About Mission Pharmacal Company
Mission Pharmacal Company is a privately held pharmaceutical company based in San Antonio, Texas. For nearly seven decades, the company has been improving the lives of people through every stage of life by identifying unmet healthcare needs and delivering innovative, high-quality prescription, over-the-counter, and dietary supplement products to meet these needs using only the purest ingredients and FDA-approved methods of manufacturing. Mission is recognized as a pioneer and leader in the therapeutic areas of women's health and urology and also offers leading products through its pediatric, dermatology, primary care, and long-term care service lines. Using an innovative business model, Mission has created wholly-owned subsidiaries, BioComp Pharma®, Inc., a generic drug marketer; Alamo Pharma Services®, Inc., a specialized contract sales organization; and ProSolus™, Inc., a transdermal drug developer and manufacturer. Mission Pharmacal is a proud national supporter of the March of Dimes Foundation®, whose mission is to improve the health of babies by preventing birth defects, premature birth, and infant mortality. To learn more, please visit missionpharmacal.com.

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