Calmour Childrens Acetaminophen Strips

Description

Children's Acetaminophen Strips, marketed under the brand name Calmour, contain 80 mg of acetaminophen per chewable strip. The product is available in two packaging options: a box containing 24 individually packed strips (NDC 82918-006-24) and a box containing 36 individually packed strips (NDC 82918-006-36). This formulation is designed as an oral chewable strip, serving as a pain reliever and fever reducer for children aged 2 to 9 years. The product is free from aspirin, ibuprofen, and alcohol.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It also provides relief from minor aches and pains associated with various conditions, including influenza, the common cold, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for pediatric use only, and specific dosing instructions must be followed to ensure safety and efficacy. Healthcare professionals should refer to the dosing chart below to determine the appropriate dosage based on the child's weight or age.

For children under 2 years of age (less than 24 lbs), consultation with a physician is required prior to administration. For children aged 2 to under 4 years (24-35 lbs), the recommended dosage is 2 strips of 80 mg every 4 to 6 hours, as needed. For children aged 4 to under 6 years (36-47 lbs), the dosage increases to 3 strips of 80 mg every 4 to 6 hours. For children aged 6 to under 9 years (48-59 lbs), the recommended dosage is 4 strips of 80 mg every 4 to 6 hours.

The administration technique involves removing the strip from the pouch and placing it in the child's mouth. It is important to allow the strip to dissolve for 45 seconds; any remaining residue can then be chewed.

Dosing should not exceed 5 doses within a 24-hour period, and healthcare professionals should ensure that the total daily dosage does not surpass the recommended limits. Careful adherence to these guidelines is essential to avoid the risk of overdose.

Contraindications

Use is contraindicated if the pouch containing the strip is open, as this may compromise the integrity and efficacy of the product. No other contraindications have been identified.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage of 5 doses within 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise patients to strictly adhere to the recommended dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to consult a healthcare professional. Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of its inactive ingredients.

Healthcare providers should inquire about any history of liver disease before recommending this product. Furthermore, caution is advised for patients who are concurrently taking the anticoagulant warfarin; consultation with a doctor or pharmacist is recommended prior to use.

While using this product, it is essential not to exceed the recommended dosage. Patients should be advised to discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, even if no signs or symptoms are apparent, as prompt intervention is vital.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients should be vigilant about the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. It is advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, and to confirm with a healthcare provider or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications.

Patients with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use. Additionally, individuals with liver disease or those taking the blood-thinning medication warfarin should consult a doctor before using this product.

During the use of this product, patients must adhere to the recommended dosage to avoid overdose. If new symptoms arise, or if there is any redness or swelling, worsening pain lasting more than 5 days, or a fever that worsens or lasts more than 3 days, patients should stop use and seek medical advice, as these may indicate a serious condition.

In the case of an overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Quick medical attention is crucial, even if no signs or symptoms are initially apparent.

Drug Interactions

No drug interactions have been identified for the medication. Additionally, there are no interactions noted between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Calmour Childrens Acetaminophen Strips (acetaminophen oral chewable 80 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 9 years may receive specific dosing based on weight. For children under 2 years of age weighing less than 24 lbs, consultation with a doctor is advised prior to use. For those aged 2 to under 4 years weighing 24-35 lbs, the recommended dosage is 2 strips of 80 mg every 4-6 hours. Children aged 4 to under 6 years weighing 36-47 lbs may take 3 strips of 80 mg every 4-6 hours, while those aged 6 to under 9 years weighing 48-59 lbs can take 4 strips of 80 mg every 4-6 hours.

Healthcare professionals should be aware of the liver warning associated with this medication; severe liver damage may occur if a child exceeds 5 doses in a 24-hour period, which is the maximum daily amount. Additionally, there is an allergy alert indicating that acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

A sore throat warning is also pertinent; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. It is recommended to ask a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Parents and caregivers should not exceed the recommended dose and should stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition.

Geriatric Use

There is no specific information regarding the use of Calmour Children's Acetaminophen Strips in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. It is advisable to monitor for potential adverse effects and to assess the appropriateness of the dosage, as older adults may have altered pharmacokinetics and pharmacodynamics. Given the lack of targeted studies or data, clinicians should evaluate the individual needs and health status of geriatric patients before prescribing this medication.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

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 medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients on the proper storage conditions for the medication, emphasizing that it should be stored below 77°F (25°C) and should not be refrigerated. Patients should be informed that using the medication from a pouch that is open is not recommended, as this may compromise the integrity of the product. Additionally, healthcare providers should instruct patients to check the lot number and expiration date on both the pouch containing the strip and the box to ensure the medication is within its effective period and has not been recalled.

Storage and Handling

The product is supplied in pouches containing strips, with specific handling and storage requirements to ensure its integrity and effectiveness. It is essential to store the product below 77°F (25°C) and to avoid refrigeration, as exposure to lower temperatures may compromise its quality.

Healthcare professionals should ensure that the pouch containing the strip remains sealed; the product must not be used if the pouch is open. For reference, the lot number and expiration date can be found on both the pouch and the outer box, which should be checked prior to use to confirm the product's validity.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4-6 hours as long as symptoms persist. Clinicians should advise patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients are also instructed to 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.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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