Father John`s Medicine

It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a 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 .

This product is available in the following dosage forms:

• Suspension, Extended Release


• Solution


• Capsule


• Syrup


• Lozenge/Troche


• Liquid


• Tablet


• Capsule, Liquid Filled


• Suspension

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.

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 .

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing use of dextromethorphan in the elderly with use in other age groups.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fluoxetine


• Linezolid


• Paroxetine


• Sibutramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Haloperidol


• Quinidine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthmaa€”Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that collects in the lungs and airways during asthma

• Diabetes (sugar diabetes)a€”Some products contain sugar and may affect control of blood glucose monitoring

• Liver diseasea€”Dextromethorphan may build up in the body and cause unwanted effects

• Chronic bronchitis or


• Emphysema or


• Mucus or phlegm with cougha€”Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases

• Slowed breathinga€”Dextromethorphan may slow the rate of breathing even further

Proper Use

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol .

Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For lozenge dosage form:
  
  
  
  • For cough:
    
    
    
    • Adults and children 12 years of age and oldera€”5 to 15 mg every two to four hours, as needed.
    
    
    • Children 6 to 12 years of agea€”5 to 15 mg every two to six hours, as needed.
    
    
    • Children 4 to 6 years of agea€”5 mg every four hours, as needed.
    
    
    • Children and infants up to 4 years of agea€”Use is not recommended .
    
    
    
    
  
  
  
  


• For syrup dosage form:
  
  
  
  • For cough:
    
    
    
    • Adults and children 12 years of age and oldera€”30 mg every six to eight hours, as needed.
    
    
    • Children 6 to 12 years of agea€”7 mg every four hours or 15 mg every six to eight hours, as needed.
    
    
    • Children 4 to 6 years of agea€”3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
    
    
    • Children and infants up to 4 years of agea€”Use is not recommended .
    
    
    
    
  
  
  
  


• For extended-release oral suspension dosage form :
  
  
  
  • For cough:
    
    
    
    • Adults and children 12 years of age and oldera€”60 mg every twelve hours, as needed.
    
    
    • Children 6 to 12 years of agea€”30 mg every twelve hours, as needed.
    
    
    • Children 4 to 6 years of agea€”15 mg every twelve hours, as needed.
    
    
    • Children and infants up to 4 years of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor . These signs may mean that you have other medical problems .

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of overdose

• Blurred vision


• Confusion


• Difficulty in urination


• Drowsiness or dizziness


• Nausea or vomiting (severe)


• Shakiness and unsteady walk


• Slowed breathing


• Unusual excitement, nervousness, restlessness, or irritability (severe)

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

• Confusion


• Constipation


• Dizziness (mild)


• Drowsiness (mild)


• Headache


• Nausea or vomiting


• Stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.