Dolex

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including colds, headaches, sore throats, and toothaches. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; the use of any other dosing device is not recommended.

Dosing is determined by the child's age as follows:

• For children under 2 years of age, consultation with a doctor is required prior to administration.

• For children aged 2 to under 4 years, the recommended dose is 5 mL.

• For children aged 4 to under 5 years, the recommended dose is 7.5 mL.

• For children aged 6 to under 8 years, the recommended dose is 10 mL.

• For children aged 9 to under 10 years, the recommended dose is 12.5 mL.

• For children aged 11 to under 12 years, the recommended dose is 15 mL.

Dosing may be repeated every 4 hours as needed while symptoms persist, with a maximum of five doses per day or as directed by a healthcare professional.

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. If there is uncertainty regarding the presence of acetaminophen in a medication, 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 the formulation.

• Exceeding the recommended dosage is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen.

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 healthcare professional promptly.

Healthcare providers should advise parents to seek medical guidance before administering this product if their child has a history of liver disease. Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin, as interactions may occur.

It is crucial to adhere strictly to the recommended dosage to avoid the risk of overdose. 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. Timely intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Parents should discontinue use and consult a healthcare provider if the child experiences worsening pain lasting more than 5 days, a fever that worsens or persists beyond 3 days, the emergence of any new symptoms, or if there is any redness or swelling present.

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 the product is taken concurrently with other medications containing acetaminophen. Patients are advised to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare professional if uncertain. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should avoid its use.

Before administering this product, it is recommended that patients consult a doctor if there is a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if any new symptoms arise, or if redness or swelling occurs.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for prompt medical attention, as this is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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. Patients are advised to verify the contents of any other medications with a healthcare provider or pharmacist if there is uncertainty regarding the presence of acetaminophen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to under 4 years, the recommended dose is 5 mL; for those aged 4 to under 5 years, the dose is 7.5 mL; for ages 6 to under 8 years, 10 mL; for ages 9 to under 10 years, 12.5 mL; and for ages 11 to under 12 years, 15 mL. Dosing may be repeated every 4 hours while symptoms persist, not exceeding five doses in a 24-hour period unless directed by a physician.

This product contains acetaminophen, and caution is advised due to the risk of severe liver damage if more than 5 doses are taken within 24 hours, which is the maximum daily amount. It is contraindicated to use this product with any other medication containing acetaminophen, whether prescription or nonprescription.

Healthcare professionals should advise parents to consult a doctor if the child has liver disease or is taking the anticoagulant warfarin. Parents should also be instructed to discontinue use and seek medical advice if the child's 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.

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. Prompt medical attention is essential for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. It is important to note that the product is primarily indicated for children and lacks comprehensive directions or warnings for adult populations, including those aged 65 and older.

Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of data may necessitate careful monitoring and individualized assessment of risks and benefits. Given the lack of established dosing guidelines for elderly patients, any potential use should be approached with prudence, ensuring that the unique health considerations of this population are taken into account.

Pregnancy

This product is not indicated for use during pregnancy. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. Acetaminophen may pose risks to the fetus; therefore, caution is advised when considering its use in this population. Dosage modifications may be necessary, and healthcare providers should be consulted for appropriate guidance regarding the use of this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when considering this medication for lactating mothers, as the potential risks and benefits have not been established.

Breastfed infants may be affected by the absence of data on excretion in breast milk and the potential impact on their health. Therefore, it is advisable for healthcare providers to evaluate the necessity of this medication in lactating mothers on a case-by-case basis, taking into account the lack of specific information.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 more than 5 doses in 24 hours is exceeded or if this product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that a healthcare professional be consulted if the patient has a history of liver disease. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Patients and caregivers are advised to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of liver damage.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Immediate action is crucial. In cases of suspected overdose, it is essential to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. This step is vital for both adults and children, as prompt medical attention can mitigate the risk of serious complications, even in the absence of noticeable symptoms.

Healthcare professionals should ensure that patients are aware of the importance of monitoring for any signs of overdose and the necessity of seeking help immediately, reinforcing that early intervention can be critical in managing the effects of an overdose effectively.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 nonprescription. If patients are uncertain whether a drug contains acetaminophen, 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 present in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if any new symptoms arise, or if there is any redness or swelling.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, as outlined in the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised 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 a carton that contains essential information for use. It is important to store the product at a temperature range of 68-77°F (20-25°C). Refrigeration is not permitted, as it may compromise the integrity of the product. Users are advised to retain the carton to access the full directions for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)