FLOWTUSS- hydrocodone bitartrate, guaifenesin liquid
Mission Pharmacal Company
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use FLOWTUSS™ safely and effectively. See full prescribing information for FLOWTUSS.
FLOWTUSS (hydrocodone bitartrate and guaifenesin) oral solution, CII
Initial U.S. Approval: 2014
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME
RECENT MAJOR CHANGES
Boxed Warning 5/2018
Indications and Usage (1) 5/2018
Dosage and Administration (2.1, 2.3) 5/2018
Contraindications (4) 5/2018
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.8, 5.9, 5.11, 5.12, 5.13, 5.14, 5.15) 5/2018
INDICATIONS AND USAGE
FLOWTUSS is a combination of hydrocodone, an opioid agonist; and guaifenesin an expectorant, indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older. (1) (1)
Important Limitations of Use (1) (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Oral solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg. ( 3)
WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS
Because opioid agonists may increase biliary tract pressure, with resultant increase in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after administration of a dose of FLOWTUSS. (5.15)
The most common adverse reactions of FLOWTUSS include: Dizziness, headache, sedation, nausea, and decreased blood pressure ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for Medication Guide.
FULL PRESCRIBING INFORMATION: CONTENTS*
5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors
7.1 Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)
FLOWTUSS is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.
Important Limitations of Use:
Administer FLOWTUSS by the oral route only.
Always use an accurate milliliter measuring device when administering FLOWTUSS to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [ see Warnings and Precautions (5.5)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.
Adults 18 years of age and older: 10 mL every 4 to 6 hours as needed, not to exceed 6 doses (60 mL) in 24 hours.
Oral solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg [ see Description ( 11) ].
Advise patients to always use an accurate milliliter measuring device when measuring and administering FLOWTUSS. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [ see Overdosage (10)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and can provide instructions for measuring the correct dose.
Hydrocodone, one of the active ingredients in FLOWTUSS, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of FLOWTUSS. Avoid concurrent use of FLOWTUSS with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur [ see Warnings and Precautions (5.8).
Concomitant use of opioids, including FLOWTUSS, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [ see Drug Interactions (7.1, 7.4)].
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.
Advise both patients and caregivers about the risks of respiratory depression and sedation if FLOWTUSS is used with benzodiazepines, alcohol, or other CNS depressants [ see Patient Counseling Information (17)] .
FLOWTUSS should not be used in patients with a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus).
Avoid the use of FLOWTUSS in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. In patients who may be susceptible to the intracranial effects of CO 2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), FLOWTUSS may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The most common adverse reactions experienced by subjects taking a single dose of FLOWTUSS in the clinical setting include the following: Central Nervous System: headache, dizziness, sedation (somnolence); Gastrointestinal System: nausea, diarrhea; Cardiovascular System: decreased blood pressure; Vascular System: hot flush.
The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with FLOWTUSS may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided [ see Warnings and Precautions ( 5.1) ].
Do not prescribe FLOWTUSS if the patient is taking a prescription MAOI (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping an MAOI drug. The use of MAOIs or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone [ see Warnings and Precautions ( 5.8) ].
Hydrocodone should be administered cautiously to persons receiving anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects [ see Warnings and Precautions ( 5.7) ].
Pregnancy Category C
There are no adequate and well controlled studies of FLOWTUSS in pregnant women. Reproductive toxicity studies have not been conducted with FLOWTUSS; however, studies are available with an individual active ingredient or related active ingredient. Hydrocodone was teratogenic in hamsters. Codeine, an opiate related to hydrocodone, increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, FLOWTUSS should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
Hydrocodone has been shown to be teratogenic in hamsters when given in a dose approximately 27 times the maximum recommended human daily dose (MRHDD) (on a mg/m 2 basis at a single subcutaneous dose of 102 mg/kg on gestation day 8). Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 40 times the MRHDD of hydrocodone (on a mg/m 2 basis at an oral dose of 120 mg/kg/day of codeine) increased resorptions and decreased fetal weight; however, these effects occurred in the presence of maternal toxicity. In studies in which rabbits and mice were dosed throughout organogenesis, doses of codeine up to approximately 20 and 100 times, respectively, the MRHDD of hydrocodone (on a mg/m 2 basis at oral doses of 30 and 600 mg/kg/day, respectively), produced no adverse developmental effects.
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
Caution should be exercised when FLOWTUSS is administered to nursing mothers. Hydrocodone is known to be excreted in human milk. No studies have been performed to determine if guaifenesin is excreted into breastmilk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from FLOWTUSS, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of FLOWTUSS in pediatric patients under 18 years of age has not been established. The use of hydrocodone in children less than 6 years of age is associated with fatal respiratory depression [ see Warnings and Precautions ( 5.2) ].
Clinical studies have not been conducted with FLOWTUSS in geriatric populations. Other reported clinical experience with the individual active ingredients of FLOWTUSS has not identified differences in responses between the elderly and patients younger than 65 years of age. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of FLOWTUSS, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.
Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, FLOWTUSS should be prescribed and administered with caution [ see Warnings and Precautions ( 5.3) ].
Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.
Overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, dizziness, ringing in the ears, confusion, blurred vision, eye problems, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdose, apnea, circulatory collapse, cardiac arrest and death may occur.
Overdosage with guaifenesin can cause depression of the central nervous system. While present in polypharmacy overdoses, one case of overdose with only significant levels of guaifenesin has been reported. Symptoms included slurred speech, shallow respirations, reduced heart rate with rhythm sinus bradycardia, followed by asystole.
Treatment of overdosage consists of discontinuation of FLOWTUSS together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.
FLOWTUSS also contains: black raspberry flavor, citric acid, D&C Red #33, FD&C Blue #1, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.
Hydrocodone bitartrate is a centrally-acting opioid antitussive and analgesic. It is affected by light and occurs as fine white crystals or crystalline powder which is derived from the opium alkaloid, thebaine. Its chemical name is morphinan-6-one, 4,5-epoxy-3-methoxy- 17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); and may be represented by the following structural formula:
Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.
Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions.
Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of hydrocodone bitartrate and guaifenesin after a single 10 mL oral dose administration of 5 mg hydrocodone bitartrate and 400 mg guaifenesin are equivalent to the respective reference solutions of 5 mL hydrocodone bitartrate (5 mg/5 mL), and 10 mL guaifenesin (200 mg/5 mL).
Following a single 10 mL oral dose of 5 mg hydrocodone bitartrate and 400 mg guaifenesin administered to 37 healthy adults, the geometric mean C max and AUC 0-inf for hydrocodone were 9.0 ng/mL and 61.2 ng·hr/mL, respectively. The median time to maximum concentration for hydrocodone was about 1.67 hours. Food has no significant effect on the extent of absorption of hydrocodone. The mean plasma half-life of hydrocodone is approximately 4 hours.
Following a single 10 mL oral dose of 5 mg hydrocodone bitartrate and 400 mg guaifenesin administered to 36 healthy adults, the geometric mean C max and AUC 0-inf for guaifenesin were 2.0 mcg/mL and 2.6 mcg·hr/mL, respectively. The median time to maximum concentration was about 25 minutes. The effect of food on guaifenesin systemic exposure is not considered to be clinically meaningful. The mean plasma half-life of guaifenesin is approximately 1 hour.
When guaifenesin and hydrocodone were administered in combination, the pharmacokinetics for each component was similar to those observed when each component was administered separately.
Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with FLOWTUSS; however, published information is available for the individual active ingredients or related active ingredients.
Carcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 23 and 65 times, respectively, the MRHDD of hydrocodone on a mg/m 2 basis).
Efficacy studies were not conducted with FLOWTUSS. Efficacy of FLOWTUSS is based on demonstration of bioequivalence to the individual comparator products [ see Clinical Pharmacology ( 12.3) ].
FLOWTUSS (hydrocodone bitartrate and guaifenesin)
oral solution is supplied as a violet-colored, black raspberry flavored
liquid containing 2.5 mg hydrocodone bitartrate
and 200 mg guaifenesin in each 5 mL. It is available in:
White HDPE bottles of 16 fl. oz. (473 mL): NDC 0178-3482-16
White HDPE bottles of 4 fl. oz. (118 mL): NDC 0178-3482-04
Store solution at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Dispense in a tight, light-resistant container, as defined in the USP, with a childresistant closure.
Advise patients not to increase the dose or dosing frequency of FLOWTUSS because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions ( 5.2) and Overdosage ( 10) ].
Advise patients to measure FLOWTUSS with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [ see Dosage and Administration ( 2) and Warnings and Precautions ( 5.10) ].
Inform patients and caregivers that potentially fatal additive effects may occur if FLOWTUSS is used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of FLOWTUSS with benzodiazepines or other CNS depressants, including alcohol [ see Warnings and Precautions ( 5.1) and Drug Interactions ( 7.1) ].
Requiring Mental Alertness
Advise patients to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as FLOWTUSS may produce marked drowsiness [ see Warnings and Precautions ( 5.5) ].
Caution patients that FLOWTUSS contains hydrocodone bitartrate and can produce drug dependence [ see Warnings and Precautions ( 5.3) ].
(hydrocodone bitartrate and guaifenesin) oral solution, C-II
What is the most important information I should know about FLOWTUSS?
FLOWTUSS is not for children under 18 years of age.
FLOWTUSS can cause serious side effects, including:
Addiction, abuse and misuse. Taking FLOWTUSS or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take FLOWTUSS exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.
Do not share your FLOWTUSS with other people.
Keep FLOWTUSS in a safe place away from children.
Life-threatening breathing problems (respiratory depression). FLOWTUSS can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking FLOWTUSS, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly or have certain other health problems. Children are at higher risk for respiratory depression. Breathing problems can happen even if you take FLOWTUSS exactly as prescribed by your healthcare provider.
Call your healthcare provider or get emergency medical help right away if anyone taking FLOWTUSS has any of the symptoms below:
Keep FLOWTUSS in a safe place away from children. Accidental use of even 1 dose of FLOWTUSS, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes FLOWTUSS, get emergency medical help right away.
Overdose and death due to medicine dosing errors. Overdose and death can happen if you measure the wrong dose of FLOWTUSS. Always use an accurate milliliter (mL) measuring device to measure the correct amount of FLOWTUSS. Do not use a household teaspoon to measure your medicine. You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking FLOWTUSS, including:
certain medicines to treat a fungal infection
certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C
Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your medicine is listed above.
Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in people who take FLOWTUSS with benzodiazepines or other central nervous system depressants, including alcohol.
Do not take benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with FLOWTUSS.
Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with FLOWTUSS.
Opioid withdrawal in a newborn. Use of FLOWTUSS during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take FLOWTUSS if you are pregnant. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
What is FLOWTUSS?
FLOWTUSS is a prescription medicine used in adults to treat a cough and to loosen mucus that you can have with a common cold. FLOWTUSS contains 2 medicines, hydrocodone and guaifenesin. Hydrocodone is an opioid (narcotic) cough suppressant. Guaifenesin is an expectorant.
FLOWTUSS is a federal controlled substance (C-II) because it contains hydrocodone that can be abused or lead to dependence. Keep FLOWTUSS in a safe place to prevent misuse and abuse. Selling or giving away FLOWTUSS may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take FLOWTUSS?
FLOWTUSS is not for children under 18 years of age. See “What is the most important information I should know about FLOWTUSS?”
Do not take FLOWTUSS if you:
have severe breathing problems (respiratory depression) or breathing problems caused by asthma. See “What is the most important information I should know about FLOWTUSS?”
have a blockage (obstruction) in your bowel such as a paralytic ileus.
are allergic to hydrocodone, guaifenesin, or any of the ingredients in FLOWTUSS. See the end of this Medication Guide for a complete list of ingredients.
Ask your healthcare provider if you have any questions about this information.
Before you take FLOWTUSS, tell your healthcare provider about all of your medical conditions, including if you:
have a drug addiction
have lung or breathing problems
have a fever and are coughing up mucus
have had a recent head injury
have had a brain tumor or other brain problem
have or have had seizures
have pain in your stomach-area (abdomen)
have constipation or other bowel problems
have bile duct or pancreas problems
have prostate problems
have problems with your urinary tract or difficulty urinating
have kidney or liver problems
have adrenal gland problems
have low blood pressure
plan to have surgery
are pregnant or plan to become pregnant. FLOWTUSS can harm your unborn baby. See “What is the most important information I should know about FLOWTUSS?”
are breastfeeding or plan to breastfeed. Hydrocodone passes into your breast milk and can cause serious side effects in your baby including increased sleepiness, breathing problems (respiratory depression), and death. It is not known if guaifenesin passes into your breast milk. You and your healthcare provider should decide if you will take FLOWTUSS or breastfeed. You should not do both. See “What should I avoid while taking FLOWTUSS?”
plan to have children. FLOWTUSS may affect the ability to have a child in females and males (fertility problems). It is not known if these fertility problems will be reversible, even after you stop taking FLOWTUSS. Talk to your healthcare provider if this is a concern for you.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking FLOWTUSS with certain other medicines can cause side effects or affect how well FLOWTUSS or the other medicines work. Do not start or stop taking other medicines without talking to your healthcare provider.
Especially tell your healthcare provider if you:
See “What is the most important information I should know about FLOWTUSS?”
take pain medicines such as opioids (narcotics).
take cold or allergy medicines that contain antihistamines or cough suppressants.
take muscle relaxants.
take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), or antipsychotics.
take medicines to lower your blood pressure.
take water pills (diuretics).
take medicines called “anticholinergics” used to treat certain health problems including asthma, chronic obstructive pulmonary disease (COPD), or stomach problems.
Ask your healthcare provider if you are not sure if you take one of these medicines.
How should I take FLOWTUSS?
See “What is the most important information I should know about FLOWTUSS?”
Take FLOWTUSS exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
Take FLOWTUSS by mouth only.
Take FLOWTUSS using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to help you measure the correct amount of FLOWTUSS. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
Do not overfill the measuring device.
Rinse your measuring device with water after each use.
If you take too much FLOWTUSS, call your healthcare provider or go to the nearest hospital emergency room right away.
Tell your healthcare provider if your cough does not get better within 5 days of treatment with FLOWTUSS.
What should I avoid while taking FLOWTUSS?
Avoid driving a car or operating machinery during treatment with FLOWTUSS. FLOWTUSS can cause you to be drowsy, slow your thinking and motor skills, and may affect your vision.
Do not drink alcohol during treatment with FLOWTUSS. Drinking alcohol can increase your chances of having serious side effects.
Avoid the use of FLOWTUSS if you:
are pregnant. Use of FLOWTUSS during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
are breastfeeding. Use of FLOWTUSS while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.
take a medicine called a monoamine oxidase inhibitor (MAOI). Avoid taking an MAOI within 14 days after you stop taking FLOWTUSS. Avoid starting FLOWTUSS if you stopped taking an MAOI in the last 14 days.
What are the possible side effects of FLOWTUSS?
FLOWTUSS can cause serious side effects, including:
See “What is the most important information I should know about FLOWTUSS?”
Bowel problems including severe constipation or stomach pain. See “Who should not take FLOWTUSS?”
Increased pressure in your head (intracranial). Avoid the use of FLOWTUSS if you have a head injury or have been told that you have changes in the tissue of your brain (brain lesions) or increased pressure in your head.
Increased risk of seizures in people with seizure disorders. If you have a seizure disorder, FLOWTUSS may increase how often you have a seizure.
Low blood pressure. A sudden drop in blood pressure can happen in some people during treatment with FLOWTUSS and this may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). Your risk of having this problem may be increased if you take FLOWTUSS with certain other medicines that lower blood pressure. If you have any of these symptoms while taking FLOWTUSS, sit or lie down. Do not change your body position too fast. Get up slowly from sitting or lying down.
Adrenal gland problems. FLOWTUSS can cause serious and life-threatening adrenal gland problems. Your healthcare provider may do blood tests to check for adrenal gland problems. Call your healthcare provider right away if you have any of these symptoms:
not wanting to eat (anorexia)
low blood pressure
The most common side effects of FLOWTUSS include:
decrease in mental and physical performance
lack of energy
These are not all the possible side effects of FLOWTUSS.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FLOWTUSS?
Store FLOWTUSS at room temperature between 68°F to 77°F (20°C to 25°C).
Store FLOWTUSS in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
Keep FLOWTUSS and all medicines out of the reach of children.
How should I dispose of FLOWTUSS?
Remove unused FLOWTUSS from the container and mix it with an undesirable, non-toxic substance such as cat litter or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash. You can also follow your state or local guidelines on how to safely throw away FLOWTUSS.
General information about the safe and effective use of FLOWTUSS.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FLOWTUSS for a condition for which it was not prescribed. Do not give FLOWTUSS to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about FLOWTUSS that is written for health professionals.
What are the ingredients in FLOWTUSS?
Active ingredients: hydrocodone bitartrate and guaifenesin
Inactive ingredients: black raspberry flavor, citric acid, D&C Red #33, FD&C Blue #1, glycerin, methylparaben, polyethylene glycol propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol
Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355
For more information, go to www.flowtuss.com or call 1-800-298-1087.
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 10/2018
hydrocodone bitartrate, guaifenesin liquid
|Labeler - Mission Pharmacal Company (008117095)|
|Registrant - Mission Pharmacal Company (008117095)|
|Mikart, Inc.||030034847||manufacture(0178-3482) , repack(0178-3482)|