Acetaminophen

Description

Acetaminophen Oral Elixir is formulated to provide 160 mg of acetaminophen per 5 mL. This product is alcohol-free and aspirin-free, making it suitable for pediatric use in children aged 2 to 11 years. The elixir is available in a grape flavor and is offered in three different volumes: 4 FL OZ (118 mL), 8 FL OZ (236 mL), and 16 FL OZ (473 mL). Manufactured by Akron Pharma, this oral elixir is designed to deliver effective pain relief and fever reduction in a palatable form for young patients.

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. Healthcare professionals should determine the appropriate dosage based on the patient's weight whenever possible; if weight is not available, age may be used as a guide.

The dosage may be repeated every 4 hours as needed, or as directed by a physician. It is important to note that no more than 5 doses should be administered within a 24-hour period, and the treatment should not exceed 5 consecutive days unless specifically directed by a healthcare provider.

Dosage Chart:

Weight (lbs.):

• Under 24: Consult Physician

• 24 to 35: 1 teaspoon (5 mL)

• 36 to 47: 1 1/2 teaspoons (7.5 mL)

• 48 to 59: 2 teaspoons (10 mL)

• 60 to 71: 2 1/2 teaspoons (12.5 mL)

• 72 to 95: 3 teaspoons (15 mL)

Age (years):

• Under 2: Consult Physician

• 2 to 3: 1 teaspoon (5 mL)

• 4 to 5: 1 1/2 teaspoons (7.5 mL)

• 6 to 8: 2 teaspoons (10 mL)

• 9 to 10: 2 1/2 teaspoons (12.5 mL)

• 11: 3 teaspoons (15 mL)

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

Additionally, it is important to adhere to the recommended dosing guidelines, as exceeding the recommended dose may pose significant health risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

Liver Warning

• 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 24 hours, particularly when used in conjunction with other medications containing acetaminophen.

• Caution is advised for adults who consume 3 or more alcoholic drinks daily while using this product, as this may increase the risk of liver damage.

Sore Throat Warning Healthcare providers should advise patients to seek medical attention if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General Precautions Before recommending this product for children, healthcare professionals should inquire about the following conditions:

• Liver disease.

• Adherence to a sodium-restricted diet.

Additionally, it is important to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin. Patients should be instructed not to exceed the recommended dosage when using this product.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation and Consultation Patients should be advised to stop using the product and consult a healthcare professional if:

• Pain worsens or persists beyond 5 days.

• Fever intensifies or lasts more than 3 days.

• New symptoms develop.

• Redness or swelling occurs.

These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if the following conditions are met: adults exceed 6 doses within a 24-hour period, children exceed 5 doses within a 24-hour period while also taking other medications containing acetaminophen, or adults consume 3 or more alcoholic drinks daily while using this product.

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. Parents should seek medical advice if their child is allergic to acetaminophen or any of the inactive ingredients in this product. Additionally, it is recommended that a doctor be consulted before use if the child has liver disease or is on a sodium-restricted diet. If the child is taking the blood-thinning medication warfarin, consultation with a doctor or pharmacist is also advised.

Patients are instructed to discontinue use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if redness or swelling is present, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt 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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may arise from unintentional duplication of therapy. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight and age. The recommended dosages are as follows: for children weighing under 24 lbs. (under 2 years), consultation with a physician is required; for those weighing 24 to 35 lbs. (2 to 3 years), the dosage is 1 teaspoonful (5 mL); for 36 to 47 lbs. (4 to 5 years), the dosage is 1 1/2 teaspoonfuls (7.5 mL); for 48 to 59 lbs. (6 to 8 years), the dosage is 2 teaspoonfuls (10 mL); for 60 to 71 lbs. (9 to 10 years), the dosage is 2 1/2 teaspoonfuls (12.5 mL); and for 72 to 95 lbs. (11 years), the dosage is 3 teaspoonfuls (15 mL).

Dosing may be repeated every 4 hours as directed by a healthcare professional, but should not exceed 5 doses in a 24-hour period or be used for more than 5 days unless directed by a doctor.

Healthcare providers should advise parents to consult a physician before use if the child has liver disease or is on a sodium-restricted diet. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is taking the anticoagulant warfarin.

Parents and caregivers should keep this medication out of reach of children and be aware of the overdose warning, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, immediate medical attention is crucial, even if no symptoms are apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Acetaminophen Elixir. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

Due to the lack of detailed information regarding geriatric use, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of Acetaminophen Elixir. Regular assessment of renal and hepatic function may also be warranted, given the increased risk of comorbidities in this population.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 following conditions are met: adults taking more than 6 doses in a 24-hour period, which is the maximum daily amount, or children taking more than 5 doses in a 24-hour period, 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 for liver damage.

It is advised that caregivers consult a physician before administering this product to children with known liver disease.

Patients should be aware of the overdose warning associated with this product. Taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially present.

Overdosage

Taking more than the recommended dose of this medication may lead to serious health consequences, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdose.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly impact the outcome and mitigate the risk of severe complications.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to inform patients that this product should not be used if their child is allergic to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than five days, fever worsens or lasts more than three days, new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Patients should also be advised to seek medical guidance before using this product if their child has liver disease, is on a sodium-restricted diet, or is taking the anticoagulant medication warfarin. Lastly, healthcare providers should stress the importance of adhering to the recommended dosage and not exceeding it while using this product.

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 15° to 30° C (59° to 86° F). Care must be taken to protect the product from freezing, as well as from exposure to light to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage that may be repeated every 4 hours, not to exceed 5 doses within a 24-hour period. Patients should not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)