Brand Names: Capital with Codeine Suspension, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

Generic Name: acetaminophen and codeine (Pronunciation: a SEET a MIN o fen and KOE deen)

• What is acetaminophen and codeine (Tylenol-Codeine)?
• What are the possible side effects of acetaminophen and codeine (Tylenol-Codeine)?
• What is the most important information I should know about acetaminophen and codeine (Tylenol-Codeine)?
• What should I discuss with my healthcare provider before taking acetaminophen and codeine (Tylenol-Codeine)?
• How should I take acetaminophen and codeine (Tylenol-Codeine)?
• What happens if I miss a dose (Tylenol-Codeine)?
• What happens if I overdose (Tylenol-Codeine)?
• What should I avoid while taking acetaminophen and codeine (Tylenol-Codeine)?
• What other drugs will affect acetaminophen and codeine (Tylenol-Codeine)?
• Where can I get more information?

What is acetaminophen and codeine (Tylenol-Codeine)?

Codeine is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

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

Acetaminophen-Codeine 300 mg-15 mg-MAL

round, white, imprinted with 2, M inside square

Acetaminophen-Codeine 300 mg-30 mg-MAL

round, white, imprinted with 3, M inside square

Acetaminophen-Codeine 300 mg-30 mg-RAN

round, white, imprinted with 3, RX 562

Acetaminophen-Codeine 300 mg-60 mg-MAL

round, white, imprinted with 4, M inside square

Acetaminophen-Codeine 300 mg-60 mg-RAN

round, white, imprinted with 4, RX 561

APAP 2-BAR

round, white, imprinted with b 302, 2

APAP 2-TEV

round, white, imprinted with 93 50, 2

APAP 3-BAR

round, white, imprinted with b 303, 3

APAP 3-QUA

round, white, imprinted with 2064 V, 3

APAP 3-TEV

round, white, imprinted with 93 150, 3

APAP 4-BAR

round, white, imprinted with B 304, 4

APAP 4-TEV

round, white, imprinted with 93 350, 4

Tylenol 3

round, white, imprinted with TYLENOL CODEINE 3, McNEIL

What are the possible side effects of acetaminophen and codeine (Tylenol-Codeine)?

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.

Call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heartbeat;
• feeling light-headed, fainting;
• confusion, unusual thoughts or behavior;
• seizure (convulsions);
• easy bruising or bleeding; or
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• feeling dizzy or drowsy;
• mild nausea, vomiting, upset stomach, constipation;
• headache;
• blurred vision; or
• dry mouth.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acetaminophen and codeine (Tylenol-Codeine)?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Do not use more of this medication than is recommended. An overdose of acetaminophen can cause serious harm. 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. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day.

Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

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.