codeine, phenylephrine, and triprolidine

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Pronunciation: KOE dee FEN il EFF rin and trye PROE li deen

Brand: Histex-AC

What is the most important information I should know about codeine, phenylephrine, and triprolidine?

Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Codeine may also be habit-forming. Never share this medicine with another person. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids. Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

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.

This medicine should not be given to a child younger than 6 years old. Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

What is codeine, phenylephrine, and triprolidine?

Codeine is a narcotic. It is a pain reliever and a cough suppressant.

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

Triprolidine 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.

Codeine, phenylephrine, and triprolidine is a combination medicine used to treat sneezing, runny or stuffy nose, cough, watery eyes, itching, and other cold or allergy symptoms.

This medicine will not treat a cough that is caused by smoking, asthma, emphysema, or bronchitis.

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

What should I discuss with my healthcare provider before taking codeine, phenylephrine, and triprolidine?

You should not use this medicine if you are allergic to codeine, phenylephrine, and triprolidine.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This medicine should not be given to a child younger than 6 years old. Always ask a doctor before giving this medicine to a child of any age. Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

To make sure this medicine is safe for you, tell your doctor if you have:

  • any type of breathing disorder, including COPD (chronic obstructive pulmonary disease);
  • cough with mucus;
  • heart disease, high blood pressure;
  • a thyroid disorder;
  • enlarged prostate, problems with urination;
  • glaucoma; or
  • kidney disease.

It is not known whether this medicine will harm an unborn baby. If you use codeine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Antihistamines may also slow breast milk production. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

How should I take codeine, phenylephrine, and triprolidine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

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

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time that you are using triprolidine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Do not freeze. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking codeine, phenylephrine, and triprolidine?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol while you are taking medicine that contains codeine.

Ask a doctor or pharmacist before using any cold, cough, or sleep medication. Many combination medicines contain antihistamines, decongestants, or cough suppressants. Taking certain products together can cause you to get too much of these medicines.

What are the possible side effects of codeine, phenylephrine, and triprolidine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop taking this medicine and call your doctor at once if you have:

  • severe drowsiness;
  • a light-headed feeling, like you might pass out;
  • weak or shallow breathing;
  • nervousness, trouble sleeping; or
  • severe constipation.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

  • feeling nervous or restless (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect codeine, phenylephrine, and triprolidine?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking codeine, phenylephrine, and triprolidine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with codeine, phenylephrine, and triprolidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about codeine, phenylephrine, and triprolidine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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