Apap Elixer (acetaminophen)

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is debossed with "APAP" on one side and "54162" on the opposite side. Each tablet contains 500 mg of acetaminophen. The formulation includes the following inactive ingredients: corn starch, microcrystalline cellulose, sodium starch glycolate, stearic acid, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and iron oxide.

Uses and Indications

This drug is indicated for the reduction of fever and the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, and premenstrual and menstrual cramps.

Additionally, this drug temporarily reduces fever. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Shake the formulation well before use. The appropriate dosage should be determined using the chart provided below; weight is the preferred method for dosing, but age may be used if weight is not available.

Dosage may be repeated every 4 hours as needed, or as directed by a healthcare professional. It is important not to exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless specifically directed by a physician.

Dosage Chart:

• For patients weighing under 24 lbs. or under 2 years of age, consult a physician for appropriate dosing.

• For patients weighing 24-35 lbs. or aged 2 to 3 years, the recommended dosage is 1 teaspoon (5 mL).

• For patients weighing 36-47 lbs. or aged 4 to 5 years, the recommended dosage is 1 1/2 teaspoons (7.5 mL).

• For patients weighing 48-59 lbs. or aged 6 to 8 years, the recommended dosage is 2 teaspoons (10 mL).

• For patients weighing 60-71 lbs. or aged 9 to 10 years, the recommended dosage is 2 1/2 teaspoons (12.5 mL).

• For patients weighing 72-95 lbs. or aged 11 to 12 years, the recommended dosage is 3 teaspoons (15 mL).

• For patients weighing over 95 lbs. or aged 12 years to adult, the recommended dosage is 4 teaspoons (20 mL).

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Additionally, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should be aware that adults should not exceed 6 doses within a 24-hour period, as this is the maximum daily amount. For children, the maximum daily amount is 5 doses within the same timeframe, particularly when other medications containing acetaminophen are also being administered. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly.

General precautions should be taken when administering this product to children. It is advisable to consult a healthcare provider if the child has liver disease or is on a sodium-restricted diet. Furthermore, prior to use, healthcare professionals should inquire about any concurrent use of the blood-thinning medication warfarin, as interactions may occur. It is essential to adhere strictly to the recommended dosage and not exceed it.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be advised to discontinue use and consult a physician if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if the following conditions are met: adults exceed 6 doses in a 24-hour period, which is the maximum daily amount, or children exceed 5 doses in a 24-hour period when taken with other drugs containing acetaminophen. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients uncertain about the presence of acetaminophen in other medications should seek guidance from a doctor or pharmacist. Furthermore, this product is contraindicated in children who are allergic to acetaminophen or any of the inactive ingredients.

Before using this product, it is recommended that patients consult a doctor if their child has liver disease or is on a sodium-restricted diet. Additionally, consultation with a doctor or pharmacist is advised if the child is taking the blood-thinning medication warfarin.

Patients must adhere to the recommended dosage and should discontinue use and seek medical advice if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

In cases of overdose, which may result from exceeding the recommended dose, patients are advised to seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Apap Elixer (acetaminophen) (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age (weighing less than 24 lbs) should be evaluated by a physician prior to use. For children aged 2 years and older, the recommended dosages are as follows:

• 2 to 3 years (24-35 lbs): 1 teaspoon (5 mL)

• 4 to 5 years (36-47 lbs): 1 ½ teaspoons (7.5 mL)

• 6 to 8 years (48-59 lbs): 2 teaspoons (10 mL)

• 9 to 10 years (60-71 lbs): 2 ½ teaspoons (12.5 mL)

• 11 to 12 years (72-95 lbs): 3 teaspoons (15 mL)

• 12 years and older (over 95 lbs): 4 teaspoons (20 mL)

It is important not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless otherwise directed by a healthcare provider.

Healthcare professionals should advise parents to consult a physician if the child has liver disease or is on a sodium-restricted diet. Additionally, consultation with a doctor or pharmacist is recommended if the child is taking the anticoagulant warfarin.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this maximum is 6 doses within a 24-hour period, while for children, it is 5 doses in the same timeframe, particularly when combined with other medications containing acetaminophen.

Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk of liver damage. It is advisable for caregivers to consult a healthcare professional before administering this product to children with known liver disease.

Patients should be aware that taking more than the recommended dose can lead to overdose, which may result in liver damage. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact a Poison Control Center without delay. This is essential for both adults and children, as timely intervention can be critical, even in the absence of noticeable signs or symptoms.

Healthcare providers should ensure that patients and caregivers are aware of the importance of rapid response in overdose situations to mitigate potential health risks effectively.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted, particularly in patients who exceed the recommended dose or have underlying liver disease. Instances of allergic reactions, including anaphylaxis, have also been documented. Furthermore, some patients have experienced gastrointestinal bleeding while taking acetaminophen, especially those with a history of gastrointestinal issues or concurrent use of anticoagulants.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: if pain worsens or persists for more than 5 days, if fever worsens or lasts longer than 3 days, if new symptoms develop, or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is on a sodium-restricted diet. It is also advisable for patients to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 15º to 30ºC (59º to 86ºF). Care must be taken to protect the product from freezing, as well as from exposure to light to ensure its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Apap Elixer (acetaminophen), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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