Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Brand Name : Dumin, Panadol, Tempra syr, Descriptions Acetaminophen is used to relieve minor aches and pain and reduce fever. Unlike aspirin, it does not relieve the redness, stiffness, or swelling caused by rheumatoid arthritis. However, it may relieve the pain caused by mild forms of arthritis. This medicine is available without a prescription. This product is available in the following dosage forms: • Solution • Tablet, Disintegrating • Suppository • Powder • Syrup • Tablet • Tablet, Chewable • Capsule • Powder for Solution • Suspension • Elixir • Tablet, Extended Release • Capsule, Liquid Filled • Liquid • Tablet, Effervescent In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of acetaminophen in children. However, do not administer the over-the-counter products to children under 2 years old unless your doctor has instructed you to do so. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen in the elderly. Pregnancy Information about this acetaminophen-oral-route-rectal-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Imatinib • Pixantrone Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Acenocoumarol • Carbamazepine • Fosphenytoin • Isoniazid • Lixisenatide • Phenytoin • Warfarin • Zidovudine Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. • Ethanol • Tobacco Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. • Cabbage Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: • Alcohol abuse, or history of or • Kidney disease, severe or • Liver disease (including hepatitis)—The chance of serious side effects may be increased. • Phenylketonuria (PKU)—Some brands of acetaminophen contain aspartame, which can make your condition worse. Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may cause an overdosage. Liver damage can occur if large amounts of acetaminophen are taken for a long time. Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours). You may take this medicine with or without food. If you are taking this medicine without the advice of your doctor, carefully read and follow the drug facts label and dosing instructions on the medicine package. This is to avoid confusion and dosing errors. Ask your doctor if you have any questions. For patients using the oral liquid with syringe (e.g. Little Fevers®): • Shake the bottle well before each use. • Measure the dose with the provided dose syringe (e.g., AccuSafe™) that comes with the package. Do not use any other syringe, dropper, spoon, or dosing device when giving this medicine to your child. • Remove the cap, attach the syringe to the flow restrictor, and invert the bottle. • Pull back the syringe until filled with the dose prescribed by your doctor. • Slowly give the medicine into your child’s mouth (towards the inner cheek). • Replace the cap back tightly. For patients using the oral liquid with dropper: • Shake the bottle well before each use. • Measure the dose with the provided dropper. Do not use any other syringe, dropper, spoon, or dosing device when giving this medicine to your child. • Remove the cap, insert the dropper and withdraw the dose prescribed by your doctor. • Slowly give the medicine into your child’s mouth (towards the inner cheek). • Replace the cap back tightly. For patients using acetaminophen oral granules (e.g., Snaplets-FR): • Just before the medicine is to be taken, open the number of packets needed for one dose. • Mix the granules inside of the packets with a small amount of soft food, such as applesauce, ice cream, or jam. • Eat the acetaminophen granules along with the food. For patients using acetaminophen oral powders (e.g., Feverall® Sprinkle Caps [Children’s or Junior Strength]): • These capsules are not intended to be swallowed whole. Instead, just before the medicine is to be taken, open the number of capsules needed for one dose. • Empty the powder from each capsule into 1 teaspoonful (5 mL) of water or other liquid. • Drink the medicine along with the liquid. You may drink more liquid after taking the medicine. • You may also mix the powder with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen powder along with the food. For patients using acetaminophen suppositories: • If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper. • To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. • For pain or fever: For oral dosage forms (capsules, granules, powders, solution, suspension, or tablets) and rectal dosage forms (suppositories): Adults and teenagers—325 or 500 milligrams (mg) every 3 or 4 hours, 650 mg every 4 to 6 hours, or 1000 mg every 6 hours as needed. The total dose should not be more than 4000 mg (for example, eight 500–mg tablets) a day for acetaminophen and 3000 mg (for example, six 500-mg tablets) a day for Tylenol® extra strength. Children—Dose is based on the child’s age, do not administer the over-the-counter products to children under the age of 2 unless directed to do so by your doctor: Children 11 to 12 years of age: 320 to 480 mg every 4 hours as needed. Children 9 to 11 years of age: 320 to 400 mg every 4 hours as needed. Children 6 to 9 years of age: 320 mg every 4 hours as needed. Children 4 to 6 years of age: 240 mg every 4 hours as needed. Children 2 to 4 years of age: 160 mg every 4 hours as needed. Children 1 to 2 years of age: 120 mg every 4 hours as needed. Infants 4 to 12 months of age: 80 mg every 4 hours as needed. Infants up to 3 months of age: 40 mg every 4 hours as needed. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze. You may store the suppositories in the refrigerator, but do not freeze them. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it. If your symptoms do not improve within a few days or if they become worse, check with your doctor. Stop using this medicine and check with your doctor or dentist right away: • If you are taking this medicine to relieve pain, including arthritis pain, and the pain lasts for more than 10 days for adults or 5 days for children or if the pain gets worse, new symptoms occur, or the painful area is red or swollen. These could be signs of a serious condition that needs medical or dental treatment. • If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, the fever gets worse, new symptoms occur, or redness or swelling is present. These could be signs of a serious condition that needs treatment. • If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting. Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Adding these medicines to the medicine that you are already taking may cause you to get more than a safe amount of acetaminophen. Talk to your doctor before taking more than one medicine that contains acetaminophen. Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem. If you will be taking more than an occasional 1 or 2 doses of acetaminophen, do not drink alcoholic beverages. To do so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly, if you take more acetaminophen than is recommended on the package label, or if you take it regularly for a long time. Taking certain other medicines together with acetaminophen may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with acetaminophen for more than a few days unless your doctor has directed you to do so and is following your progress: • Aspirin or other salicylates • Diclofenac (e.g., Voltaren®) • Diflunisal (e.g., Dolobid®) • Etodolac (e.g., Lodine®) • Fenoprofen (e.g., Nalfon®) • Floctafenine (e.g., Idarac®) • Flurbiprofen, oral (e.g., Ansaid®) • Ibuprofen (e.g., Motrin®) • Indomethacin (e.g., Indocin®) • Ketoprofen (e.g., Orudis®) • Ketorolac (e.g., Toradol®) • Meclofenamate (e.g., Meclomen®) • Mefenamic acid (e.g., Ponstel®) • Nabumetone (e.g., Relafen®) • Naproxen (e.g., Naprosyn®) • Oxaprozin (e.g., Daypro®) • Phenylbutazone (e.g., Butazolidin®) • Piroxicam (e.g., Feldene®) • Sulindac (e.g., Clinoril®) • Tenoxicam (e.g., Apo-Tenoxicam®) • Tiaprofenic acid (e.g., Surgam®) • Tolmetin (e.g., Tolectin®). Acetaminophen may interfere with the results of some medical tests. Before you have any medical tests, tell the person in charge if you have taken acetaminophen within the past 3 or 4 days. If possible, it is best to call the laboratory where the test will be done about 4 days ahead of time, to find out whether this medicine may be taken during the 3 or 4 days before the test. For diabetic patients: • Acetaminophen may cause false results with some blood glucose (sugar) tests. If you notice any change in your test results, or if you have any questions about this possible problem, check with your doctor. This is especially important if your diabetes is not well-controlled. For patients taking one of the products that contain caffeine in addition to acetaminophen: • Caffeine may interfere with the results of a test that uses adenosine (e.g., Adenocard®) or dipyridamole (e.g., Persantine®) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for 8 to 12 hours before the test. If you think that you or anyone else may have taken an overdose of acetaminophen, get emergency help at once, even if there are no signs of poisoning. Signs of severe poisoning may not appear for 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started as soon as possible. Treatment started more than 24 hours after the overdose is taken may not be effective. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Rare • Bloody or black, tarry stools • bloody or cloudy urine • fever with or without chills (not present before treatment and not caused by the condition being treated) • pain in the lower back and/or side (severe and/or sharp) • pinpoint red spots on the skin • skin rash, hives, or itching • sore throat (not present before treatment and not caused by the condition being treated) • sores, ulcers, or white spots on the lips or in the mouth • sudden decrease in the amount of urine • unusual bleeding or bruising • unusual tiredness or weakness • yellow eyes or skin Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose • Diarrhea • increased sweating • loss of appetite • nausea or vomiting • stomach cramps or pain • swelling, pain, or tenderness in the upper abdomen or stomach area Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects.