Histinex® HC is a clear, orange-colored, sugar free, alcohol free syrup with characteristic fruity odor for oral administration.

Each teaspoonful (5 mL) contains:

Hydrocodone Bitartrate* ............................................2.5 mg
Phenylephrine Hydrochloride ......................................5.0 mg
Chlorpheniramine Maleate ........................................2.0 mg

Antitussive/nasal decongestant/antihistamine syrup for oral administration.

Also contains citric acid, FD&C Yellow No. 6 (Sunset Yellow), flavorings, glycerin, hydrochloric acid, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium hydroxide, sodium phosphate dibasic and sorbitol solution.

*(Warning: May be habit forming)

Last updated on RxList: 4/9/2009

Histinex® HC is indicated for the symptomatic relief of cough, nasal congestion and discomfort associated with upper respiratory tract infections.

Adults and pediatric patients over 12 years - 2 teaspoonsful (10 mL) every 4 hours, not to exceed 8 teaspoonsful in 24 hours. Pediatric patients 6 to 12 years - 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonsful in 24 hours. Pediatric patients under 6 years - use only as directed by a physician.

Bottles of 16 fl. oz. (473 mL) NDC 58177-877-07

Bottles of 32 fl. oz. (946 mL) NDC 58177-877-12

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at controlled room temperature, 59°-86°F (15°-30°C)

Dispense in tight, child resistant, light-resistant containers as defined by the USP/NF.

Manufactured by: KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO 63043-2413. Rev. 10/98.

Last updated on RxList: 4/9/2009

Adverse reactions to Histinex® HC may include hypersensitivity reactions such as rash, urticaria, leukopenia, agranulocytosis and thrombocytopenia, drowsiness, lassitude, giddiness, dryness of the mucous membranes, tightness of the chest, thickening of bronchial secretions, urinary frequency and dysuria, palpitation, hypertension/hypotension, headache, faintness, dizziness, tinnitus, incoordination, visual disturbances, mydriasis, CNS depressant and (less often) stimulant effect, increased irritability or excitement, anorexia, nausea, vomiting, diarrhea, constipation and epigastric distress.

Drug Abuse And Dependence

This product is a Schedule III Controlled Substance. Because of the hydrocodone content, some abuse might be expected. Psychic dependence, physical dependence and tolerance may deveolop upon repeated administration. It should be prescribed and administered with the degree of caution appropriate for this type product.

No information provided.

Last updated on RxList: 4/9/2009

No information provided.

Administer with care in patients with cardiac or peripheral vascular diseases or hypertension. Until the patient's response has been determined, he should be cautioned against engaging in operations which require alertness, such as driving an automobile, operating machinery, etc. Patients receiving antihistamines should be warned against possible additive effects with CNS depressants such as alcohol, hypnotics, sedatives, tranquilizers, etc. Since hydrocodone may produce drowsiness, persons who perform hazardous tasks requiring mental alertness or physical coordination should be cautioned accordingly.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with Histinex® HC Syrup.

Pregnancy

Teratogenic Effects. Pregnancy category C. Animal reproduction studies have not been conducted with Histinex® HC Syrup. It is also not known whether Histinex® HC Syrup can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Histinex® HC Syrup should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Histinex® HC Syrup, a decision should be made whether to discontinue nursing or discontinue the drug, taking into the account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 has not been established.

Geriatric Use

Clinical studies of Histinex® HC syrup did not include sufficient numbers of subjects aged 65 and over to determine whetherthey respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, 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.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Histinex® HC syrup and observed closely.

Last updated on RxList: 4/9/2009

No information provided.

Hypersensitivity to antihistamines of the same chemical class. Histinex® HC is contraindicated during pregnancy and in concurrent therapy with MAO inhibitors. Because of its drying effect on lower respiratory secretions, Histinex® HC is not recommended in the treatment of bronchial asthma.

Last updated on RxList: 4/9/2009

Histinex® HC reduces excessive nasal secretions, diminishes edema of the nasal mucosa and congestion of the upper respiratory tract and abolishes or diminishes cough. The antihistaminic action of chlorpheniramine maleate reduces or abolishes allergenic responses of nasal tissue. Its action is complemented by the mild vasoconstrictor action of phenylephrine hydrochloride which provides a nasal decongestant effect. Cough suppression is a result of the action of hydrocodone bitartrate.

Last updated on RxList: 4/9/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 4/9/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

DECONGESTANT/NARCOTIC ANTITUSSIVE/ANTIHISTAMINE - ORAL

USES: This combination product is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Decongestants help relieve stuffy nose symptoms. This product also contains a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.

If your product contains hydrocodone (cough suppressant), do not use it in children younger than 6 years unless specifically directed by the doctor. If your product contains another cough suppressant, do not use it in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., giving saline nose drops/spray, using a humidifier or infant nasal suction bulb).

HOW TO USE: Take this medication by mouth with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs. Dosage is based on your medical condition, age, and response to treatment. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.

If you are using a liquid form, use a medication-measuring device or spoon to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.

If you are using sustained-release tablets or capsules, swallow the medication whole. Do not crush, chew, or break the tablets or capsules. Doing so can destroy the long action of the drug and may increase side effects.

This medication may cause dependence, especially if it has been used regularly for an extended time (more than a few weeks) or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and diarrhea. Report any such reactions to your doctor immediately. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

SIDE EFFECTS: Drowsiness, dizziness, headache, blurred vision, upset stomach, nausea, constipation, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, hallucinations), ringing in the ears, shaking (tremors), slow/shallow breathing, trouble urinating, weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, fast/slow/irregular heartbeat, seizure.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to it; or to tartrazine; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison's disease), certain brain disorders (e.g., head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), diabetes, a certain eye problem (glaucoma), heart problems, high blood pressure, kidney problems, liver disease, mental/mood problems (e.g., depression, psychosis), seizures, stomach/intestinal problems (e.g., ulcers, blockage), thyroid problems (e.g., hyperthyroidism, hypothyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention), use/abuse of drugs/alcohol.

This drug may make you dizzy or drowsy or cause blurred vision; use caution engaging in activities requiring alertness such as driving or using machinery. Limit the use of alcohol and certain other drowsiness-causing medications. (See also Drug Interactions.) To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.

This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of this product.

The elderly may be more sensitive to the effects of this drug, especially dizziness, drowsiness, mental/mood changes, and blood pressure changes.

Do not give this medication to a child under 2 years unless directed to do so by a doctor. In young children, this medication may cause agitation/excitement instead of drowsiness.

During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell your doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This product should not be used with the following medications because very serious (rarely fatal) interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), sibutramine.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. Avoid taking MAO inhibitors within 2 weeks of starting or stopping this medication.

Before taking this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: other anticholinergic drugs (e.g., benztropine, belladonna alkaloids), beta blockers (e.g., metoprolol, atenolol), cimetidine, guanethidine, certain inhaled anesthetics (e.g., halothane), memantine, methyldopa, narcotic antagonists (e.g., naltrexone, naloxone), reserpine, scopolamine, tricyclic antidepressants (e.g., amitriptyline, desipramine).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could affect your heart rate/blood pressure or cause drowsiness. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: confusion, cold/clammy skin, fast/slow/irregular heartbeat, slow/shallow breathing, seizures, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law.

Do not take this medication for several days before allergy testing because test results can be affected.

MISSED DOSE: If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.