Promethazine HCl and Dextromethorphan Hydrobromide Syrup

DRUG DESCRIPTION

Each teaspoon (5 mL) of Promethazine HCl and Dextromethorphan Hydrobromide (promethazine and dextromethorphan) Syrup contains 6.25 mg promethazine HCl and 15 mg dextromethorphan hydrobromide in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are artificial and natural flavors, citric acid, D&C Yellow 10, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, water, and other ingredients.

Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.

Promethazine HCl, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10- ethanamine, N,N, ?-trimethyl-, monohydrochloride, (±)- with the following structural formula:

Promethazine HCl structural formula illustration

Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.

Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9?, 13?, 14?- morphinan hydrobromide monohydrate with the following structural formula:

Dextromethorphan hydrobromide structural formula illustration

Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C18H25NO•HBr•H2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan HBr monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line).

What are the possible side effects of dextromethorphan and promethazine (Promethazine with Dextromethorphan, Promethazine with DM)?

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

Stop using dextromethorphan and promethazine and call your doctor at once if you have any of these serious side effects:

  • uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremors, twitching, or uncontrolled muscle movements in your face, arms, or legs.
  • ...

Read All Potential Side Effects and See Pictures of Promethazine HCl and Dextromethorphan Hydrobromide Syrup »

What are the precautions when taking promethazine and dextromethorphan (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to promethazine or to dextromethorphan; or to any other phenothiazines (such as prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema, sleep apnea), heart problems (such as slow/irregular heartbeat, chest pain), liver problems, difficulty urinating (such as due to an enlarged prostate), stomach/bowel problems (such as blockage, ulcer), high blood pressure, diabetes, a certain eye...

Read All Potential Precautions of Promethazine HCl and Dextromethorphan Hydrobromide Syrup »


Promethazine HCl and Dextromethorphan Hydrobromide Syrup Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, nausea, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

If you are very sleepy or have difficulty waking up after using this medication, stop taking this medication and talk to your doctor or pharmacist immediately. Your dosage may need to be lower.

Remember that your doctor has prescribed this medication because 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: decreased coordination, difficulty urinating, shaking (tremor).

Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: fast/slow/irregular heartbeat, fainting, slow/shallow breathing, mental/mood changes (such as nervousness, excitement, irritability, confusion, hallucinations), abnormal/involuntary movements (such as fixed upward stare, neck twisting, tongue movements).

Promethazine may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, muscle stiffness, severe confusion, sweating, seizures, fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to promethazine or to dextromethorphan; or to any other phenothiazines (such as prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema, sleep apnea), heart problems (such as slow/irregular heartbeat, chest pain), liver problems, difficulty urinating (such as due to an enlarged prostate), stomach/bowel problems (such as blockage, ulcer), high blood pressure, diabetes, a certain eye problem (glaucoma), seizures, blood/immune system problems (such as bone marrow depression).

This drug may make you dizzy/drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. Children should be supervised to avoid injury during bicycle riding or other possibly hazardous activities.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Liquid forms of this medication may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery or procedures such as X-rays with dye, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the effects of the drug, especially breathing problems such as slow/shallow breathing. Children may also experience excitability rather than drowsiness. Special caution should be taken in children with a family history of sudden infant death syndrome (SIDS), those who have a severe loss of fluid (dehydration), and those who are hard to wake up from sleep.

Older adults may be more sensitive to the effects of the drug, especially drowsiness and confusion.

During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Promethazine HCl and Dextromethorphan Hydrobromide Syrup Patient Information Including Side Effects

Brand Names: Promethazine with Dextromethorphan, Promethazine with DM

Generic Name: dextromethorphan and promethazine (Pronunciation: dex troe me THOR fan and pro METH a zeen)

  • What is dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What are the possible side effects of dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What is the most important information I should know about dextromethorphan (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What should I discuss with my healthcare provider before taking dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • How should I take dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What happens if I miss a dose (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What happens if I overdose (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What should I avoid while taking dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • What other drugs will affect dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?
  • Where can I get more information?

What is dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Promethazine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

The combination of dextromethorphan and promethazine used to treat cough, itching, runny nose, sneezing, and itchy or watery eyes caused by colds or allergies.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and promethazine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dextromethorphan and promethazine (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?

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

Stop using dextromethorphan and promethazine and call your doctor at once if you have any of these serious side effects:

  • uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremors, twitching, or uncontrolled muscle movements in your face, arms, or legs.
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • hallucinations (seeing or hearing things);
  • confusion, hallucinations; or
  • slow, shallow breathing, weak pulse;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, muscle stiffness, confusion, fast or uneven heartbeat, sweating, fainting.

Keep taking dextromethorphan and promethazine and talk with your doctor if you have any of these less serious side effects:

  • dizziness, drowsiness, sleepiness, or confusion;
  • blurred vision, dry mouth;
  • ringing in your ears;
  • nausea or vomiting; or
  • increased sensitivity to sunlight.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dextromethorphan (Promethazine HCl and Dextromethorphan Hydrobromide Syrup)?

Call your doctor immediately if you experience uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use dextromethorphan and promethazine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dextromethorphan and promethazine before the MAO inhibitor has cleared from your body.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

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