Acetaminophen; Diphenhydramine Solution

What is this medication?

ACETAMINOPHEN; DIPHENHYDRAMINE (a set a MEE noe fen; dye fen HYE dra meen) treats pain and helps you go to sleep faster. It is a combination of acetaminophen and an antihistamine.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Theraflu Multi-Symptom Severe Cold, Tylenol Cold Nighttime, Tylenol PM Extra Strength, Tylenol Sore Throat Nighttime

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asthma or lung disease
• Frequently drink alcohol
• Glaucoma
• Heart disease
• High blood pressure
• Liver disease
• Pain or difficulty passing urine
• Prostate trouble
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to acetaminophen, diphenhydramine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medication may also interact with the following:

• Alcohol
• Barbiturates, such as phenobarbital
• Certain medications for bladder problems, such as oxybutynin, tolterodine
• Certain medications for blood pressure
• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for movement abnormalities or Parkinson disease
• Certain medications for stomach problems, such as chlordiazepoxide, dicyclomine
• Imatinib
• Isoniazid
• Medications for sleep
• Other medications for cold, cough, or allergy
• Other medications with acetaminophen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

This medication may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Do not take other medications that contain acetaminophen with this medication. Many non-prescription medications contain acetaminophen. Always read labels carefully. If you have questions, ask your care team.

If you take too much acetaminophen, get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Trouble passing urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Drowsiness
• Headache
• Nausea
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.