Tylenol Arthritis Pain

• It is used to ease pain and fever.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
• Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
• Talk with your doctor before you drink alcohol.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Tylenol Arthritis Pain.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Different brands of Tylenol Arthritis Pain may have different doses for children. Talk with the doctor before giving this medicine to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Tylenol Arthritis Pain while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Store at room temperature. Do not refrigerate or freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Store in original container.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tylenol Arthritis Pain, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tylenol Arthritis Pain (acetaminophen controlled-release tablets). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Tylenol Arthritis Pain.

Review Date: October 4, 2017

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 gelcaps in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• the tablet got stuck in your throat
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

• do not take more than directed (see overdose warning)

• store at 20–25°C (68–77°F). Avoid high humidity.
• do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken
• see end panel for lot number and expiration date

Applies to acetaminophen: compounding powder, intravenous solution, oral capsule, oral granule effervescent, oral liquid, oral powder for reconstitution, oral suspension, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, rectal suppository

General

In general, acetaminophen (the active ingredient contained in Tylenol Arthritis Pain) is well-tolerated when administered in therapeutic doses. The most commonly reported adverse reactions have included nausea, vomiting, constipation. Injection site pain and injection site reaction have been reported with the IV product.[Ref]

Hepatic

Common (1% to 10%): Increased aspartate aminotransferase
Rare (less than 0.1%): Increased hepatic transaminases
Frequency not reported: Liver failure[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), Vomiting (up to 15%)
Common (1% to 10%): Abdominal pain, diarrhea, constipation, dyspepsia, enlarged abdomen
Frequency not reported: Dry mouth[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, hypersensitivity reactions[Ref]

Hematologic

Common (1% to 10%): Anemia, postoperative hemorrhage
Very rare (less than 0.01%): Thrombocytopenia, leucopenia, neutropenia[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Very rare (less than 0.01%): Pemphigoid reaction, pustular rash, Lyell syndrome
:[Ref]

Respiratory

Common (1% to 10%): Dyspnea, abnormal breath sounds, pulmonary edema, hypoxia, pleural effusion, stridor, wheezing, coughing[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, hypertension, hypotension, tachycardia, chest pain[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, hyperglycemia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Dystonia

Musculoskeletal

Common (1% to 10%): Muscle spasms, trismus

Psychiatric

Common (1% to 10%): Insomnia, anxiety

Genitourinary

Common (1% to 10%): Oliguria

Local

Common (1% to 10%): Infusion site pain, injection site reactions

Ocular

Common (1% to 10%): Periorbital edema

Other

Common (1% to 10%): Pyrexia, fatigue
Rare (0.01% to 0.1%): Malaise

Some side effects of Tylenol Arthritis Pain may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.