Histex-DM

What is Histex-DM?

Histex-DM is a medicine that is used to treat nose stuffiness. It is used to ease allergy signs. Histex-DM is also used to relieve coughing.

Before taking Histex-DM, tell your doctor:

• If you are allergic to Histex-DM; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a cough with a lot of mucus.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.
• If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Histex-DM with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Histex-DM?

• Tell all of your health care providers that you take Histex-DM. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Histex-DM for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Histex-DM affects you.
• Avoid drinking alcohol while taking Histex-DM.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Histex-DM while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Histex-DM best taken?

Use Histex-DM as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Measure liquid doses carefully. Use the measuring device that comes with Histex-DM. If there is none, ask the pharmacist for a device to measure Histex-DM.

What do I do if I miss a dose?

• If you take Histex-DM on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Histex-DM is taken on an as needed basis. Do not take more often than told by the doctor.

What are the side effects of Histex-DM that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Histex-DM?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Histex-DM?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 473 ML BOTTLE LABEL

• NDC 28595-804-16
• Antihistamine • Decongestant
  Cough Suppressant
• HISTEX™-DM
  Syrup
• Each teaspoonful (5 mL)
  contains:
  Dextromethorphan HBr  20 mg
  Phenylephrine HCl         10 mg
  Triprolidine HCl            2.5 mg
• Sugar-Free • Dye Free
  Alcohol Free
• Grape Flavor
• 16 fl oz (473 mL)

SRC: NLM .