Elixsure Fever / Pain

You should not use this medication if you have severe liver disease.

An overdose of acetaminophen can damage your liver or cause death.

• Adults and teenagers who weigh at least 110 pounds should not take more than 1000 milligrams (mg) at one time, or more than 4000 mg in 24 hours.

• Children younger than 12 years old should not take more than 5 doses in 24 hours, using only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.

Avoid also using other medicines that contain acetaminophen (sometimes abbreviated as APAP), or you could have a fatal overdose.

Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

You should not take acetaminophen if you are allergic to it, or if you have severe liver disease.

Do not take acetaminophen without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.

Your doctor will determine whether acetaminophen is safe for you to use during pregnancy. Do not use this medicine without the advice of your doctor if you are pregnant.

Acetaminophen can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more than your recommended dose. An overdose of acetaminophen can damage your liver or cause death.

• Adults and teenagers who weigh at least 110 pounds (50 kilograms): Do not take more than 1000 milligrams (mg) at one time. Do not take more than 4000 mg in 24 hours.

• Children younger than 12 years old: Do not take more than 5 doses of acetaminophen in 24 hours. Use only the number of milligrams per dose that is recommended for the child's weight and age. Use exactly as directed on the label.

• Avoid also using other medicines that contain acetaminophen, or you could have a fatal overdose.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen.

You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

Applies to acetaminophen: capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, acetaminophen (the active ingredient contained in Elixsure Fever / Pain) 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 while taking acetaminophen:

• 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 while taking acetaminophen:

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area

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 Elixsure Fever / 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 Elixsure Fever / Pain may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.