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Dolex Children

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Active ingredient
Ibuprofen 100 mg/100 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
August 6, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/100 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
August 6, 2020
Manufacturer
Pharmadel LLC
Registration number
ANDA210602
NDC root
55758-304
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

DOLEX CHILDREN is a medication designed to help relieve minor aches and pains that can occur due to common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it is effective in reducing fever, making it a useful option for managing discomfort associated with these ailments.

This medication works by temporarily alleviating pain and lowering elevated body temperature, providing you with relief when you or your child are feeling unwell.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage closely and never exceed the amount directed. To prepare the medication, shake the bottle well before each use.

To find the right dose for you or your child, refer to the dosing chart provided. If possible, use weight to determine the dose; if not, you can use age. Make sure to use only the enclosed dosing cup for measuring, as other devices may not provide accurate measurements. If you need to repeat the dose, you can do so every 6 to 8 hours, but remember not to take more than four doses in a single day.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to Ibuprofen or any other pain reliever or fever reducer. Additionally, do not use it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries risks of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach bleeding signs (like faintness, vomiting blood, or black stools), or any heart-related symptoms (such as chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor before using ibuprofen if your child has any underlying health issues or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information regarding the use of DOLEX Children Ibuprofen during pregnancy is limited. The available text does not provide specific statements about its safety or any associated risks while pregnant. Additionally, there are no dosage modifications or special precautions mentioned for pregnant individuals.

While there are no clear contraindications noted, it's always best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor first. For children aged 2-3 years weighing 24-35 pounds, the recommended dose is 5 mL, while those aged 4-5 years and weighing 36-47 pounds should take 7.5 mL. The dosage increases with weight and age, reaching 15 mL for an 11-year-old weighing 72-95 pounds.

It's important to consult a doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, or has not been drinking enough fluids due to vomiting or diarrhea. Additionally, seek medical advice if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than 3 days, or if any new symptoms arise, stop using the medication and consult a doctor.

Geriatric Use

When considering the use of DOLEX Children Ibuprofen for older adults, it's important to note that the drug insert does not provide specific information about how it should be used in this age group. This means there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it's always a good idea to consult with a healthcare professional before starting any new medication, including over-the-counter options like ibuprofen. They can help ensure that the medication is safe and appropriate based on individual health needs.

Renal Impairment

If you or your child has kidney disease, it's important to consult with a doctor before using this medication. Kidney problems can affect how your body processes certain drugs, so getting professional advice ensures safety and proper care. Always prioritize your health by discussing any concerns with your healthcare provider.

Hepatic Impairment

If you have liver problems, such as cirrhosis (severe liver scarring), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working). This is crucial to ensure that the medication is safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when your child is taking medications. For instance, if your child is allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases significantly. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with your healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any potential interactions is crucial to ensure your child's safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the printed neckband on the bottle is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of your product.

Additional Information

You should take this medication orally, and it's a good idea to take it with food or milk if you experience any stomach upset. If you notice any concerning symptoms in a child, such as signs of stomach bleeding, heart problems, or stroke, or if the pain or fever worsens or lasts more than three days, stop using the medication and consult a doctor. Additionally, if the child does not feel better within the first 24 hours, or if you see any redness or swelling in the painful area, seek medical advice.

FAQ

What is DOLEX CHILDREN used for?

DOLEX CHILDREN relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

How should I dose DOLEX CHILDREN?

Use the enclosed dosing cup and find the right dose on the chart based on your child's weight or age. Do not exceed the recommended dose.

What should I do if my child experiences stomach bleeding?

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I give DOLEX CHILDREN to my child if they have asthma?

Consult a doctor before use if your child has asthma or any other serious condition.

What are the signs of a severe allergic reaction to DOLEX CHILDREN?

Signs may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Seek medical help immediately if these occur.

Is it safe to use DOLEX CHILDREN during pregnancy?

The provided information does not mention specific risks or contraindications for using DOLEX CHILDREN during pregnancy.

What should I do if my child does not get relief from DOLEX CHILDREN?

If your child does not experience relief within the first day (24 hours) of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

How should I store DOLEX CHILDREN?

Store DOLEX CHILDREN between 20-25°C (68-77°F) and do not use if the carton is opened or the bottle neckband is broken or missing.

Packaging Info

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

Packaging configurations for Dolex Children.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DOLEX CHILDREN is a pediatric formulation designed for the relief of pain and fever. It is available in a liquid dosage form, specifically as an oral suspension. The product is characterized by its distinct appearance, which is a clear, pale yellow liquid. The active ingredient is acetaminophen, which has a molecular weight of 151.16 g/mol and a chemical formula of C8H9NO2. Inactive ingredients include glycerin, sorbitol, and flavoring agents, which contribute to the overall formulation and palatability for children.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific guidance:

  • For patients weighing under 24 lbs or under 2 years of age, consult a physician for appropriate dosing.

  • For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

  • For patients weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

  • For patients weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

It is critical not to exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those concurrently using other NSAIDs, including aspirin, ibuprofen, or naproxen. Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, with the exception of aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Furthermore, ibuprofen should not be used for more than two days or administered to children under three years of age unless directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential of severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's direction.

Patients should discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical attention. Furthermore, if a child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of new symptoms should also prompt a discussion with a healthcare provider.

Ibuprofen should not be used in children with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, nor should it be administered immediately before or after heart surgery.

Prior to using ibuprofen, it is essential to consult a healthcare professional if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for children who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Children with asthma or those taking diuretics should also seek medical advice before use.

Lastly, it is recommended to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if necessary.

Additionally, the risk of stomach bleeding is further elevated when ibuprofen is used in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and evaluate the necessity of multiple NSAID therapies in these cases.

For children who are prescribed diuretics, it is advisable to consult a healthcare professional prior to initiating ibuprofen therapy to ensure safe and effective use.

Packaging & NDC

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

Packaging configurations for Dolex Children.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age as follows:

  • Under 24 lbs: Under 2 years: Consult a doctor

  • 24-35 lbs: 2-3 years: 5 mL

  • 36-47 lbs: 4-5 years: 7.5 mL

  • 48-59 lbs: 6-8 years: 10 mL

  • 60-71 lbs: 9-10 years: 12.5 mL

  • 72-95 lbs: 11 years: 15 mL

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is recommended if the child has not been adequately hydrated due to vomiting or diarrhea, or if there are pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

If the child is taking a diuretic, a doctor should also be consulted. Parents should be instructed to stop use and seek medical advice if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond 3 days, or if any new symptoms arise.

Geriatric Use

There is no specific information regarding the use of DOLEX Children Ibuprofen in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for adverse effects and therapeutic efficacy is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

There are no specific statements regarding the use of DOLEX Children Ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with the use of ibuprofen during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the benefits against any potential risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of the impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with cirrhosis or significant liver disease, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy.

Additionally, patients with a history of liver disease, including those with high blood pressure, heart disease, or prior strokes, should be evaluated carefully, as these conditions may further complicate the management of their hepatic status.

Healthcare providers should consider these factors when determining the appropriate therapeutic regimen for patients with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have indicated occurrences of gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which include anaphylaxis and various skin reactions. Additionally, cases of liver injury have been documented. There have also been reports of cardiovascular events, such as heart attack and stroke, linked to the use of NSAIDs, including ibuprofen. Furthermore, serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted in postmarketing reports.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, healthcare providers should inform patients to stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is important to advise patients to consult a doctor if the child does not experience any relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

Patients should be counseled to take the product with food or milk if stomach upset occurs.

Healthcare providers should recommend that patients consult a doctor before use if any of the following apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had adverse reactions to pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic.

Lastly, patients should be advised to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a secure carton, and it is essential to ensure that the carton remains unopened and that the printed bottle neckband is intact. If either of these conditions is not met, the product should not be used.

For optimal storage, the product must be kept at a temperature range of 20-25°C (68-77°F). It is important to check the bottom panel of the carton for the lot number and expiration date to ensure the product's validity and safety.

Additional Clinical Information

The medication is administered orally. Patients are advised to take it with food or milk if they experience stomach upset. Clinicians should counsel patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, fails to achieve relief within the first 24 hours, experiences worsening fever or pain lasting more than three days, shows redness or swelling in the painful area, or develops any new symptoms.

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

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Dolex Children, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.