When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to aspirin, caffeine, codeine, or dihydrocodeine. This medicine is not meant for use in children. Serious breathing problems and deaths have occurred when children have been given codeine.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is not for long-term use.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how aspirin/caffeine/dihydrocodeine works. Tell your doctor if you are using a blood thinner (such as warfarin).
• Alcohol, allergy medicine, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you drink alcohol or use other medicine that makes you sleepy or lightheaded.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, breathing problems (such as sleep apnea), blood clotting problems, or stomach ulcers.
• Do not breastfeed while you are using this medicine, unless you have your doctor's permission to do so.
• This medicine may cause respiratory depression in some people, even when used as directed. Signs of respiratory depression or overdose include shallow breathing, confusion, and severe sleepiness.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Extreme dizziness, drowsiness, or weakness
• Tremors or muscle cramps
• Trouble breathing, slow heartbeat or breathing, and cold, clammy skin

If you notice these less serious side effects, talk with your doctor:

• Constipation, nausea, vomiting
• Rash or itching skin

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088