D-Tann HC

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medication with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough medicine.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Diphenhydramine, hydrocodone, and phenylephrine is a combination medicine used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

Diphenhydramine, hydrocodone, and phenylephrine may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use this medicine if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of diphenhydramine, hydrocodone, and phenylephrine.

Cough/cold combinations are used mainly to relieve the cough due to colds, influenza, or hay fever. They are not to be used for the chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Cough/cold combination products contain more than one ingredient. For example, some products may contain an antihistamine, a decongestant, and an analgesic, in addition to a medicine for coughing. If you are treating yourself, it is important to select a product that is best for your symptoms. Also, in general, it is best to buy a product that includes only those medicines you really need. If you have questions about which product to buy, check with your pharmacist.

Since different products contain ingredients that will have different precautions and side effects, it is important that you know the ingredients of the medicine you are taking. The different kinds of ingredients that may be found in cough/cold combinations include:

Antihistamines—Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Some examples of antihistamines contained in these combinations are:

• Bromodiphenhydramine
• Brompheniramine
• Carbinoxamine
• Chlorpheniramine
• Dexchlorpheniramine
• Diphenhydramine
• Doxylamine
• Phenindamine
• Pheniramine
• Phenyltoloxamine
• Pyrilamine
• Promethazine
• Triprolidine

Decongestants—Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion. However, this effect may also increase blood pressure in patients who have high blood pressure. These include:

• Ephedrine
• Phenylephrine
• Pseudoephedrine

Antitussives—Antitussives help relieve coughing and are some contain a narcotic. These antitussives act directly on the cough center in the brain. Narcotics may become habit-forming, causing mental or physical dependence, if used for a long time. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

Narcotic antitussives
• Codeine
• Dihydrocodeine
• Hydrocodone
• Hydromorphone

Non-narcotic antitussives
• Carbetapentane
• Caramiphen
• Dextromethorphan

Expectorants—Expectorants work by loosening the mucus or phlegm in the lungs. The main expectorant used in cough and cold medicines is guaifenesin. Other ingredients added as expectorants (for example, ammonium chloride, calcium iodide, iodinated glycerol, ipecac, potassium guaiacolsulfonate, potassium iodide, and sodium citrate) have not been proven to be effective. In general, the best thing you can do to loosen mucus or phlegm is to drink plenty of water.

Analgesics—Analgesics are used in these combination medicines to help relieve the aches and pain that may occur with the common cold. These include:

• Acetaminophen
• Aspirin
• Other salicylates such as salicylamide and sodium salicylate

The use of too much acetaminophen and salicylates at the same time may cause kidney damage or cancer of the kidney or urinary bladder. This may occur if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

Anticholinergics—Anticholinergics, such as homatropine may help produce a drying effect in the nose and chest.

These cough and cold combinations are available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

If your cough has not improved after 7 days or if you have a high fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

• Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic cough medicine (dihydrocodeine, hydrocodone, or hydromorphone):

• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

For patients taking antihistamine-containing medicine:

• Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.
• This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
• This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally.
• Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
• When taking antihistamines on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as in arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.
• Antihistamines may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients taking decongestant-containing medicine:

• This medicine may add to the central nervous system (CNS) stimulant effects of diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor.
• This medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing medicine:

• This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
• This medicine may cause some people to become drowsy, dizzy, less alert than they are normally, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
• Nausea or vomiting may occur after taking a narcotic antitussive. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.
• Dizziness, lightheadedness, or fainting may be especially likely to occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking iodide (calcium iodide, iodinated glycerol, or potassium iodide)-containing medicine:

• Make sure your doctor knows if you are planning to have any future thyroid tests. The results of the thyroid test may be affected by the iodine in this medicine.

For patients taking analgesic-containing medicine:

• Check the label of all nonprescription (over-the-counter [OTC]), and prescription medicines you now take. If any contain acetaminophen or aspirin or other salicylates, including diflunisal or bismuth subsalicylate, be especially careful. Taking them while taking a cough/cold combination medicine that already contains them may lead to overdose. If you have any questions about this, check with your health care professional.
• Do not take aspirin-containing medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For diabetic patients taking aspirin- or sodium salicylate-containing medicine:

• False urine sugar test results may occur:
  • If you take 8 or more 325-mg doses of aspirin every day for several days in a row.
  • If you take 8 or more 325-mg or 4 or more 500-mg doses of sodium salicylate.
• Smaller doses or occasional use of aspirin or sodium salicylate usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

For patients taking homatropine-containing medicine:

• This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Applies to diphenhydramine / hydrocodone / phenylephrine: oral suspension extended release, oral syrup

Nervous system

Nervous system side effects have included lightheadedness, nervousness, dizziness, drowsiness, sedation, mental clouding, headache, insomnia, tremors, weakness, lethargy, hallucinations, convulsions, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, itchy and prickly sensations, and mood changes.[Ref]

Gastrointestinal

Gastrointestinal side effects have included difficulty swallowing, dry mouth, anorexia, nausea, vomiting, and heartburn.[Ref]

Genitourinary

Genitourinary side effects have included ureteral spasm, spasm of vesicle sphincters, urinary retention, and dysuria.[Ref]

Cardiovascular

Cardiovascular side effects have included pallor, tachycardia, palpitations, irregular heart beat, arrhythmias and cardiovascular collapse with hypotension.[Ref]

Respiratory

Respiratory side effects have included respiratory difficulty and shortness of breath.[Ref]

Ocular

Ocular side effects have included blurring of vision.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of dermatitis.[Ref]

Some side effects of D-Tann HC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-2 mg-7.5 mg/5 mL:
10 mL orally every 4 hours not to exceed 40 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 12.5 mg-3.5 mg-5 mg/5 mL:
10 mL orally every 4 to 6 hours not to exceed 40 mL daily.

Diphenhydramine/hydrocodone/phenylephrine 25 mg-3.5 mg-7.5 mg/5 mL:
5 mL to 10 mL orally every 12 hours.

Data not available