Aspirin, ASA; Caffeine; Dihydrocodeine capsules

What is this medicine?

ASPIRIN; CAFFEINE; DIHYDROCODEINE (AS pir in; KAF een; dye hye droe KOE deen) is a pain reliever. It is used to treat moderate to severe pain.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not for use in children less than 12 years of age. Do not give this medicine to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• anxious

• breathing problems

• confusion

• fast, irregular heartbeat

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• ringing in the ears

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble passing urine or change in the amount of urine

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

• constipation

• dry mouth

• nausea, vomiting

• stomach pain

• tiredness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cidofovir

• defibrotide

• ketorolac

• methotrexate

• probenecid

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• certain medicines for anxiety or sleep

• certain medicines for asthma

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

• certain medicines for seizures like phenobarbital, primidone

• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• local anesthetics like lidocaine, pramoxine, tetracaine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines that relax muscles for surgery

• other aspirin and aspirin-like medicines

• other narcotic medicines for pain or cough

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• procarbazine

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.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature at 25 degrees C (77 degrees F).

What should I tell my health care provider before I take this medicine?

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

• blood clotting problems

• drug abuse or addiction

• head injury

• heart, circulation problems

• kidney disease

• liver disease

• lung or breathing disease

• stomach ulcer, intestine problems

• an unusual or allergic reaction to aspirin, caffeine, dihydrocodeine, codeine, or other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking it because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medicines (opiates). If you take more than one type at the same time or if you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

Too much aspirin can be very dangerous. Do not take aspirin or medicines that contain aspirin with this medicine. Many non-prescription medicines contain aspirin. Always read the labels carefully.

This medicine can irritate your stomach or cause bleeding problems. Do not smoke cigarettes or drink alcohol. Do not lie down for 30 minutes after taking this medicine to prevent irritation to your throat.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

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

Children may be at higher risk for side effects. If your child has slow breathing, noisy breathing, confusion, or unusual sleepiness, stop giving this medicine and get medical help right away.