Nortemp

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headaches, sore throat, and toothaches.

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

Dosage and Administration

The dosage of this medication is determined primarily by the patient's weight; however, age may be used as an alternative reference. It is imperative that only the enclosed dropper designed for this product is utilized for dosing, as other devices may lead to inaccurate measurements.

For patients weighing under 24 pounds and under 2 years of age, it is recommended to consult a physician for appropriate dosing. For patients weighing between 24 and 35 pounds and aged 2 to 3 years, the prescribed dose is 1.6 mL, which can be administered as two separate doses of 0.8 mL each.

To ensure accurate dosing, healthcare professionals should instruct caregivers to fill the dropper to the designated dose level. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The medication may be given alone or mixed with formula, milk, juice, or other suitable liquids.

If necessary, the dose may be repeated every 4 hours; however, it is crucial not to exceed 5 doses within a 24-hour period. For administration, caregivers should fill the dropper to 0.8 mL or the prescribed level and dispense the liquid with a single firm squeeze of the dropper bulb.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

• This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

• Exceeding the recommended dosage is contraindicated; adherence to dosage guidelines is essential to prevent overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise parents and caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Before administering this product, it is essential to consult a healthcare provider if the child has a history of liver disease. Additionally, if the child is currently taking warfarin or any other blood-thinning medication, it is advisable to seek guidance from a doctor or pharmacist prior to use to avoid potential drug interactions.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Rapid medical intervention is crucial, even if no symptoms are immediately apparent.

Parents and caregivers should discontinue use and consult a healthcare professional if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts longer than three days. These signs may indicate a serious condition that necessitates further medical assessment.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and severe throat conditions.

Severe liver damage may occur if patients exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or if they concurrently use other medications containing acetaminophen.

In addition, patients should be vigilant for symptoms associated with sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Patients are advised to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists for more than three days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 be heightened, leading to serious hepatic complications. 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 Nortemp (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 pounds or under 2 years of age should consult a doctor before use. For children weighing between 24 to 35 pounds, aged 2 to 3 years, the recommended dose is 1.6 mL, administered as two 0.8 mL doses.

It is essential to use only the enclosed dropper designed for this product to ensure accurate dosing. The dropper should be filled to the 0.8 mL mark or the prescribed level, and the medication should be dispensed with a single firm squeeze of the dropper bulb.

Warnings include a liver warning indicating that severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount, or if used concurrently with other medications containing acetaminophen. Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. The use of this product should be carefully considered in light of these risks.

Dosage adjustments may be necessary for pregnant patients; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Additionally, special precautions should be taken to monitor for any adverse effects during use, and any such effects should be reported to a healthcare provider immediately.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of acetaminophen is exceeded. Specifically, patients should not exceed five doses within a 24-hour period. Additionally, caution is advised when administering this product in conjunction with other medications that also contain acetaminophen, as this may further increase the risk of liver damage. Regular assessment of liver function is recommended to ensure patient safety and to mitigate potential adverse effects associated with hepatic impairment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in assessing the total dosage of acetaminophen administered to the child, including any additional medications that may contain acetaminophen.

Concomitant Use with Other Acetaminophen-Containing Products The risk of severe liver damage is further heightened if the product is taken concurrently with other medications that also contain acetaminophen. It is essential for healthcare providers to evaluate the complete medication history of the patient to prevent unintentional overdose.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

Prompt recognition and intervention are crucial in mitigating the risks associated with acetaminophen overdosage.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the drug. Reports include allergic reactions such as skin rash, hives, and itching. Instances of liver damage have been noted, particularly in cases of overdose or prolonged use. Gastrointestinal disturbances, including nausea and vomiting, have also been reported. Renal impairment has occurred in rare cases. Hematological reactions, such as thrombocytopenia and leukopenia, have been documented. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed. Anaphylaxis has been reported in rare instances.

These reactions were reported voluntarily from a population of uncertain size, making it challenging to reliably estimate their frequency or establish a causal relationship to drug exposure. The safety profile of acetaminophen continues to be monitored through postmarketing surveillance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to communicate the overdose warning, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is critical even if no signs or symptoms are initially present.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a doctor or pharmacist.

Healthcare providers should also inquire about any known allergies, specifically to acetaminophen or any inactive ingredients in the product, particularly in children. It is advisable to ask a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Patients should be instructed to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious condition. Lastly, it is crucial to remind patients not to exceed the recommended dosage while using this product, reiterating the importance of adhering to the overdose warning.

Storage and Handling

The product is supplied in a configuration that includes a dropper. It is essential to store the product at a temperature range of 20°-25°C (68°-77°F) to ensure its stability and efficacy.

To maintain child resistance, the dropper must be replaced tightly after each use. Proper handling and storage conditions are crucial for preserving the integrity of the product.

Additional Clinical Information

The medication is administered orally and can be given alone or mixed with formula, milk, or juice. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking warfarin, a blood-thinning medication. Patients should discontinue use and seek medical advice if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

Drug Information (PDF)

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

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