Aphen

Description

Acetaminophen is a non-opioid analgesic and antipyretic agent, available in a dosage form of 325 mg per tablet. It is commonly used for the relief of mild to moderate pain and the reduction of fever. The chemical formula for acetaminophen is C8H9NO2, and its molecular weight is 151.16 g/mol. The tablets are typically white to off-white in appearance.

Uses and Indications

This drug is indicated for 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, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless advised by a doctor.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake should not exceed 5 tablets, and use should be limited to a maximum of 5 days unless directed by a healthcare provider.

For children under 6 years of age, it is advised to consult a doctor before administration.

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

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to the specified guidelines. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur under the following circumstances:

• An adult consumes more than 4,000 mg of acetaminophen in a 24-hour period.

• A child exceeds 5 doses in 24 hours, which is the maximum recommended amount.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should be vigilant regarding the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. Should any of these reactions occur, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed. Patients with a history of liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur:

• Pain worsens or persists for more than 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• New symptoms develop.

• Redness or swelling is observed, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, while children should not exceed 5 doses within the same timeframe, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Prior to using this product, individuals with liver disease should consult a healthcare professional. Additionally, those taking the blood-thinning medication warfarin are advised to seek guidance from a doctor or pharmacist before use.

Patients are instructed to stop using acetaminophen and consult a healthcare provider if pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years. Furthermore, if fever worsens or lasts more than 3 days, or if new symptoms arise, medical advice should be sought. The presence of redness or swelling may indicate a serious condition, warranting immediate medical attention.

In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. 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 Aphen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets (1,625 mg) in a 24-hour period. Use should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years of age, consultation with a doctor is advised prior to use. If pain worsens or persists for more than 5 days in children under 12 years, or if fever worsens or lasts more than 3 days, parents or caregivers should discontinue use and seek medical advice.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of liver disease. It is essential for both adults and children aged 12 years and older to adhere to the recommended dosage of 2 tablets every 4 to 6 hours while symptoms persist, with a maximum limit of 10 tablets within a 24-hour period, unless otherwise directed by a physician.

In geriatric patients, careful monitoring is advised, particularly if symptoms do not improve or if pain worsens. If pain persists for more than 10 days, it is crucial to discontinue use and seek medical advice. Quick medical attention is important for elderly patients, even in the absence of noticeable signs or symptoms, to ensure safety and appropriate management of their condition.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 medication 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. It is advised that individuals with liver disease consult a healthcare professional prior to use. The maximum daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe.

Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen in 24 hours, a child exceeds 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for serious adverse effects, careful monitoring of liver function is recommended for patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding animal pharmacology and toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, (310) 320-0100.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be instructed to consult with their healthcare provider before using this medication if they have a history of liver disease. Additionally, it is important for patients to discuss any current medications with their healthcare provider or pharmacist, particularly if they are taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

The product is supplied in packaging that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief, with a maximum of 10 tablets in a 24-hour period unless otherwise directed by a physician. The duration of use should not exceed 10 days without medical guidance. For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours, not to exceed 5 tablets in 24 hours, and should not be used for more than 5 days unless directed by a healthcare provider. For children under 6 years of age, consultation with a doctor is recommended prior to administration.

Drug Information (PDF)

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

View product document (PDF)