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Bactimicina Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
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 2014
Label revision date
January 7, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
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 2014
Label revision date
January 7, 2026
Manufacturer
DLC Laboratories, Inc.
Registration number
M013
NDC root
24286-1550
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Bactimicina® is a natural oral suspension designed for children ages 2 to 11 years. It is alcohol-free and does not contain ibuprofen or aspirin. Each 5 mL dose contains 160 mg of acetaminophen, which helps reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, headaches, sore throats, and toothaches.

With a pleasant cherry flavor, Bactimicina® has been a trusted choice for families since 1978, providing a gentle option for managing discomfort in young children.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold and flu, as well as headaches, sore throats, and toothaches.

This medication is designed to help you feel more comfortable when you're not feeling your best, making it easier to manage everyday ailments.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. To ensure safety, always follow the recommended dosage and never exceed the directed amount, as doing so can lead to an overdose.

When you're ready to use the medication, make sure to shake the bottle well. You’ll need to measure the correct dose using the enclosed dosage cup, which is specially designed for this product—do not use any other measuring device. To find the right dose, refer to the dosage chart based on your child's weight or age. For example, if your child weighs between 24-35 pounds (or is 2-3 years old), the dose is 5 mL (1 teaspoon). You can repeat the dose every 4 hours as long as symptoms persist, but remember not to give more than 5 doses in a 24-hour period.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child is allergic to acetaminophen or any of its inactive ingredients.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always be mindful of these guidelines to ensure safe use of the medication.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. It's important to avoid using this product with any other acetaminophen-containing medications and to check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. Always stop use and contact a doctor if pain or fever worsens or lasts longer than the specified time, or if new symptoms arise.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Before using this product, it's important to ask a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. If your child's pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop using the product and contact a doctor. New symptoms, redness, or swelling should also prompt a call to your healthcare provider, as these could indicate a more serious condition.

Overdose

If your child takes more than 5 doses of acetaminophen in a 24-hour period, this can lead to severe liver damage. It's important to be aware that combining acetaminophen with other medications that also contain acetaminophen increases the risk of this serious side effect.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or abdominal pain. If you notice any of these symptoms or if you believe your child has taken too much acetaminophen, seek immediate medical help. Always remember to keep track of all medications your child is taking to avoid accidental overdoses.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of acetaminophen during pregnancy has not been established. Before using this medication, you should consult your doctor, as there may be potential risks to your fetus. It's essential to carefully consider whether you need to use acetaminophen and to discuss this with your healthcare provider.

If your doctor determines that you can use acetaminophen, be aware that dosage adjustments may be necessary. Always follow their guidance to ensure the safest approach for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When giving medication to your child, it's important to follow specific age and weight guidelines. For children under 2 years who weigh less than 24 lbs, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 lbs, the recommended dose is 5 mL (1 teaspoon). As your child grows, the dosage increases: 7.5 mL (1½ teaspoons) for ages 4-5 years (36-47 lbs), 10 mL (2 teaspoons) for ages 6-8 years (48-59 lbs), 12.5 mL (2½ teaspoons) for ages 9-10 years (60-71 lbs), and 15 mL (3 teaspoons) for 11-year-olds (72-95 lbs). You can repeat the dose every 4 hours as needed, but do not exceed 5 doses in a 24-hour period.

Be aware of safety concerns, as taking more than 5 doses in a day can lead to severe liver damage. Additionally, watch for any signs of an allergic reaction, such as skin reddening, blisters, or rash, and seek medical help immediately if these occur. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor. Always check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. In case of an overdose, seek medical assistance or contact a Poison Control Center right away, even if your child shows no symptoms.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional guidance.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially affecting how they work in your body. For example, if you take acetaminophen (a common pain reliever) along with warfarin (a blood thinner), it may increase the effects of warfarin, which can raise your risk of bleeding. If you find yourself using both, your healthcare provider may want to monitor your INR (a blood test that measures how long it takes your blood to clot) more closely to ensure your safety.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs and supplements. This conversation is crucial to avoid any unexpected interactions and to ensure that your treatment is as safe and effective as possible.

Storage and Handling

To ensure the best use of your product, store it at room temperature. A dosage cup is provided to help you measure the correct amount safely. Before using, check that the printed bottle wrap is intact; do not use the product if it is missing or broken, as this could compromise safety. Additionally, make sure to check the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

If your child experiences any skin reactions, stop using the medication immediately and seek medical help. Additionally, if a sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, you should consult a doctor right away.

FAQ

What is Bactimicina®?

Bactimicina® is an alcohol-free oral suspension that reduces pain and fever, suitable for children aged 2-11 years. It contains acetaminophen and has a cherry flavor.

What does Bactimicina® treat?

Bactimicina® temporarily reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

How should I dose Bactimicina®?

Use the enclosed dosage cup to measure the dose based on your child's weight or age. Repeat doses can be given every 4 hours, but do not exceed 5 doses in 24 hours.

What should I do if my child has a severe sore throat?

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any warnings associated with Bactimicina®?

Yes, Bactimicina® contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

Can I use Bactimicina® if my child is allergic to acetaminophen?

No, do not use Bactimicina® if your child is allergic to acetaminophen or any inactive ingredients in the product.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately, as quick medical attention is critical for children.

Is Bactimicina® safe to use during pregnancy?

The safety of acetaminophen during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

What should I do if my child experiences a skin reaction?

If a skin reaction occurs, such as reddening, blisters, or rash, stop use and seek medical help right away.

How should Bactimicina® be stored?

Store Bactimicina® at room temperature and do not use if the printed bottle wrap is missing or broken.

Packaging Info

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

Packaging configurations for Bactimicina Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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 the common cold, flu, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients, and specific dosing instructions must be followed to ensure safety and efficacy. Prior to administration, the product should be shaken well.

Dosing should be determined based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The following dosing chart provides the recommended doses:

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

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL (1 teaspoonful).

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL (1½ teaspoonfuls).

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL (2 teaspoonfuls).

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL (2½ teaspoonfuls).

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL (3 teaspoonfuls).

Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. It is imperative to use only the enclosed dosage cup specifically designed for this product; other dosing devices should not be utilized to ensure accurate dosing.

Healthcare professionals should be aware that this product does not contain complete warnings for adult use, and caution should be exercised to avoid exceeding the recommended dosage.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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 patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

  • Exceeding the recommended dose is contraindicated, as it poses a 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 dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 essential to consult a healthcare professional promptly.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant medication warfarin.

Emergency Medical Help Should a skin reaction occur, it is critical to stop use and seek emergency medical help immediately.

Discontinuation and Consultation Parents or guardians should discontinue use and contact a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, or who take this product in conjunction with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a 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 without delay.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in other medications should consult a doctor or pharmacist. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within.

Patients with liver disease should seek medical advice prior to using this product. Furthermore, those taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist before use.

While using this product, patients must adhere to the recommended dosage and should not exceed it. They 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 new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding complications. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both acetaminophen and warfarin to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been identified.

Packaging & NDC

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

Packaging configurations for Bactimicina Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lbs should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lbs, the recommended dose is 5 mL (1 tsp). For those aged 4 to 5 years weighing 36-47 lbs, the dose increases to 7.5 mL (1½ tsp). Children aged 6 to 8 years weighing 48-59 lbs should receive 10 mL (2 tsp), while those aged 9 to 10 years weighing 60-71 lbs may take 12.5 mL (2½ tsp). Finally, for children aged 11 years weighing 72-95 lbs, the dose is 15 mL (3 tsp).

Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Caution is advised, as severe liver damage may occur if more than 5 doses are administered within this timeframe.

Pediatric patients may experience severe skin reactions to acetaminophen, including skin reddening, blisters, or rash. If any of these symptoms occur, use should be discontinued immediately, and medical assistance should be sought. Additionally, 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.

Before use, it is important to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical attention is critical, and caregivers should contact a Poison Control Center, even if no signs or symptoms are present.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, the use of acetaminophen should be carefully considered. Dosage adjustments may be necessary, and it is essential for healthcare providers to offer guidance on appropriate dosing. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 adjustments in dosage 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 cases of overdosage, significant health risks may arise, particularly concerning liver function.

Risk of Severe Liver Damage Administration of more than five doses of acetaminophen within a 24-hour period poses a substantial risk of severe liver damage in pediatric patients. It is crucial for healthcare professionals to monitor the total daily intake of acetaminophen to prevent exceeding this maximum recommended dosage.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar adverse effects. This combination can inadvertently increase the total dosage, heightening the risk of liver toxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should assess the patient's clinical status and consider the need for liver function tests. Prompt intervention may be necessary to mitigate potential liver damage, and treatment options should be discussed based on the severity of the situation.

It is imperative for healthcare professionals to educate caregivers about the importance of adhering to dosing guidelines and the risks associated with exceeding recommended dosages.

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

No postmarketing experience details are available in the insert text.

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 medication if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the product. 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 new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

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, including the potential for overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use.

Storage and Handling

The product is supplied with a dosage cup included for accurate measurement. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to inspect the packaging carefully; the product should not be used if the printed bottle wrap is missing or broken. For reference, the lot number and expiration date can be found on the bottom panel of the container.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to 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 the anticoagulant warfarin.

In the event of a skin reaction, patients must discontinue use and seek immediate medical attention. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should promptly consult a healthcare professional.

Drug Information (PDF)

This file contains official product information for Bactimicina Childrens Pain and Fever, 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 Bactimicina Childrens Pain and Fever, 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.

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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.