acetaminophen, diphenhydramine, and phenylephrine

Generic Name: acetaminophen, diphenhydramine, and phenylephrine (a SEET a MIN oh fen, DYE fen HYE dra meen, and FEN il EFF rin)Brand names: Benadryl Allergy & Cold, Benadryl Allergy & Sinus Headache, Sudafed PE Severe Cold, Theraflu Severe Cold & Cough Nighttime, Theraflu Warming Flu & Sore Throat, Theraflu Warming Severe Cold Nighttime, Benadryl Allergy & Cold, Benadryl Allergy & Sinus Headache, Sudafed PE Nighttime Cold, Theraflu Warming Flu & Sore Throat, Theraflu Severe Cold & Cough Nighttime

What is acetaminophen, diphenhydramine, and phenylephrine?

Acetaminophen is a pain reliever and fever reducer.

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

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

The combination of acetaminophen, diphenhydramine, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, sneezing, itchy nose, itchy or watery eyes, sore throat, cough, headache, and pain or fever caused by allergies or the common cold.

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

Acetaminophen, diphenhydramine, and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen, diphenhydramine, and phenylephrine?Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not use this medication 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. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as "APAP"), diphenhydramine, or phenylephrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.What should I discuss with my healthcare provider before taking acetaminophen, diphenhydramine, and phenylephrine?Do not use this medication 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 a decongestant before the MAO inhibitor has cleared from your body. Do not take this medication if you are allergic to acetaminophen, diphenhydramine, or phenylephrine.

Ask a doctor or pharmacist if it is safe for you to use this medication if you have:

• a cough that produces mucus (phlegm);

• heart disease or high blood pressure;

• liver disease, alcoholism, or cirrhosis of the liver;

• glaucoma;

• kidney disease;

• diabetes;

• a thyroid disorder;

• an enlarged prostate; or

• problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take acetaminophen, diphenhydramine, and phenylephrine?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine should be taken only for a short time until your symptoms clear up.

An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One packet of acetaminophen, diphenhydramine, and phenylephrine powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take this medication with food or milk if it upsets your stomach. Drink extra fluids while you are taking acetaminophen, diphenhydramine, and phenylephrine.

Measure the liquid form of this 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.

Talk with your doctor if you have severe sore throat pain that lasts longer than 2 days, or if you also have a fever, headache, nausea, vomiting, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medication at room temperature, away from heat, light, and moisture.

See also: Acetaminophen, diphenhydramine, and phenylephrine dosage in more detail

What happens if I miss a dose?

Since cold or allergy medicine is usually taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include feeling restless or nervous, dizziness, drowsiness, dry mouth, warmth or tingly feeling, and seizure (convulsions).

What should I avoid while taking acetaminophen, diphenhydramine, and phenylephrine?

Avoid using an anti-itch skin cream, gel, or spray that contains diphenhydramine while you are taking this medication. Diphenhydramine can be absorbed through your skin and you may get too much if you are also taking diphenhydramine orally (by mouth).

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP"), diphenhydramine, and phenylephrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, diphenhydramine, or phenylephrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Acetaminophen, diphenhydramine, and phenylephrine side effects

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 this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• confusion, hallucinations, unusual thoughts or behavior;

• severe dizziness, anxiety, restless feeling, or nervousness;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• urinating less than usual or not at all; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dizziness, drowsiness;

• blurred vision;

• dry mouth;

• mild stomach pain, constipation;

• problems with memory or concentration;

• feeling restless or excited (especially in children);

• sleep problems (insomnia); or

• warmth, tingling, or redness under your skin.

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.

Acetaminophen, diphenhydramine, and phenylephrine Dosing Information

Usual Adult Dose for Cold Symptoms:

APAP/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg oral tablet, orAPAP/diphenhydramine/phenylephrine 325 mg-25 mg-5 mg oral tablet:2 tablets orally every 4 hours not to exceed 12 tablets daily.APAP/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/15 mL oral syrup:30 mL orally every 4 hours not to exceed 180 mL daily.APAP/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg oral powder for reconstitution (one packet):one packet dissolved in 8 oz hot water orally every 4 hours; sip while hot. Consume entire drink within 10 to 15 minutes. Do not exceed 6 packets in 24 hours.

Usual Pediatric Dose for Cold Symptoms:

APAP/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg oral tablet:12 yrs or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.6 yrs to 11 yrs: 1 tablet orally every 4 hours not to exceed 5 tablets daily.APAP/diphenhydramine/phenylephrine 325 mg-25 mg-5 mg oral tablet:12 yrs or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.APAP/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/15 mL oral syrup12 yrs or older: 30 mL orally every 4 hours not to exceed 180 mL daily.APAP/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg oral powder for reconstitution (one packet):12 yrs or older: one packet dissolved in 8 oz hot water orally every 4 hours; sip while hot. Consume entire drink within 10 to 15 minutes. Do not exceed 6 packets in 24 hours.

What other drugs will affect acetaminophen, diphenhydramine, and phenylephrine?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by diphenhydramine.

Before taking this medication, tell your doctor if you are using any of the following drugs:

• an antidepressant;

• a bronchodilator;

• a diuretic (water pill);

• gout medications;

• blood pressure medication;

• medication to treat irritable bowel syndrome;

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

• seizure medication;

• isoniazid;

• zidovudine (Retrovir, AZT);

• aspirin or salicylates such as Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Tricosal, and others; or

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, diphenhydramine, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, diphenhydramine, and phenylephrine.

• 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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Copyright 1996-2006 Cerner Multum, Inc. Version: 1.07. Revision Date: 12/08/2009 12:32:45 PM.