Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Fast Acting

Last content change checked dailysee data sync status

Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
August 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
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 2023
Label revision date
August 13, 2025
Manufacturer
Randob Labs. , Ltd.
Registration number
M013
NDC root
52412-912
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Pedia Care® is a fast-acting oral suspension specifically designed for infants and children. It contains acetaminophen (160 mg per 5 mL), which is a common pain reliever and fever reducer. This medication is formulated to help reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

With a natural grape flavor and no added alcohol, Pedia Care® is made with kids in mind, ensuring a gentle approach to managing discomfort without the use of ibuprofen or aspirin.

Uses

You can use this medication to help 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 provide you with relief when you're feeling under the weather, making it easier to manage everyday discomforts.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosage chart based on their weight or age. If your child weighs under 24 pounds or is under 2 years old, it’s best to consult a doctor for guidance. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. As your child grows, the dose increases: 7.5 mL for ages 4 to 5 years (36 to 47 pounds), 10 mL for ages 6 to 8 years (48 to 59 pounds), 12.5 mL for ages 9 to 10 years (60 to 71 pounds), and 15 mL for an 11-year-old (72 to 95 pounds).

When you’re ready to give the medication, remove the child protective cap and squeeze the correct dose into the dosing cup. Remember, you should not give this medication more than five times in a 24-hour period, and always follow the directions provided to avoid giving too much. If you have any questions or concerns, don’t hesitate to reach out to your healthcare provider.

What to Avoid

You should avoid using this medication if you or your child are allergic to acetaminophen or any of the inactive ingredients in the product. Additionally, it is important not to take this medication alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you are uncertain about whether a medication contains acetaminophen, please consult with a doctor or pharmacist for guidance.

Be mindful that combining medications can lead to serious health risks, so always check labels and seek professional advice when needed. Your safety is a priority, and understanding these guidelines can help prevent potential complications.

Side Effects

You should be aware that 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. Additionally, acetaminophen may cause serious skin reactions, including symptoms like skin reddening, blisters, or rash. If any of these skin reactions occur, 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 also important to avoid using this product if your child is allergic to acetaminophen or any of its inactive ingredients. Always check with a doctor if your child has liver disease or is taking blood thinners like warfarin. If pain or fever worsens or lasts longer than the specified time, or if new symptoms arise, stop use and consult a doctor, as these could indicate a serious condition. In case of overdose, seek medical help immediately.

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 cautious of potential severe skin reactions, such as reddening, blisters, or rash. If any of these symptoms occur, 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. Avoid using this product if your child is allergic to acetaminophen or any of its inactive ingredients, and check with a doctor if your child has liver disease or is taking the blood thinner warfarin. Always follow the recommended dosage and stop use if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling.

In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are visible.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but it’s always better to be safe and get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious about the medications you take. Currently, there is no specific information available regarding the use of acetaminophen during pregnancy, which means there are no established safety concerns, dosage changes, or special precautions outlined for its use.

Before taking any medication, including acetaminophen, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual situation. Your health and the health of your baby are paramount, so always seek professional advice when considering medication during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it may pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution and seek professional advice to ensure the safety of both you and your baby.

Pediatric Use

When giving this medication to your child, it's important to follow the correct dosage based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36 to 47 pounds), 10 mL for ages 6 to 8 years (48 to 59 pounds), 12.5 mL for ages 9 to 10 years (60 to 71 pounds), and 15 mL for 11-year-olds (72 to 95 pounds).

Be cautious, as this product contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in a 24-hour period. Always check with a doctor if your child has liver disease or is taking the blood thinner warfarin. In case of an overdose, seek medical help immediately, even if there are no symptoms. Remember to use the enclosed dosing cup for accurate measurement and never exceed the recommended dose.

Geriatric Use

It's important to note that there is no specific information available about the use of this product in older adults. This means that the guidelines and warnings typically provided for adult use may not fully apply to you or your loved ones.

If you are considering this product for an older adult, it’s wise to consult with a healthcare professional. They can help determine if this medication is appropriate, taking into account any unique health needs or conditions that may be present. Always prioritize safety and ensure that any treatment plan is tailored to the individual’s circumstances.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this product. This medication contains acetaminophen, which can be harmful to the liver. Be aware that taking more than 5 doses in a 24-hour period—this is the maximum daily amount—or using other medications that also contain acetaminophen can lead to severe liver damage. Always follow your healthcare provider's guidance to ensure your child's safety.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning medication. Mixing these can increase the risk of bleeding, so it's crucial to ensure safety.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Always prioritize open communication with your healthcare provider to ensure safe and effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms.

FAQ

What is Pedia Care®?

Pedia Care® is a fast-acting oral suspension designed specifically for kids, containing acetaminophen (160mg per 5 mL) in a natural grape flavor.

What does Pedia Care® do?

Pedia Care® reduces fever and relieves minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for Pedia Care®?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lb should take 5 mL.

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 Pedia Care®?

Yes, do not exceed 5 doses in 24 hours, and avoid using it with other drugs containing acetaminophen. Severe liver damage may occur if these guidelines are not followed.

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

No, do not use Pedia Care® if your child is allergic to acetaminophen or any of the 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 at 1-800-222-1222.

Is Pedia Care® safe for nursing mothers?

Nursing mothers should consult a doctor before using Pedia Care®, as there is potential for excretion in breast milk.

How should Pedia Care® be stored?

Store Pedia Care® at room temperature and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Fast Acting.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 52412-912-01. Pedia Care® is a fast-acting oral suspension formulated specifically for infants, containing acetaminophen as the active ingredient at a concentration of 160 mg per 5 mL. This product serves as a pain reliever and fever reducer. Each package contains 1 FL OZ (30 mL) of the suspension, which is free from added alcohol, ibuprofen, aspirin, and parabens. The formulation features a natural grape flavor and is intended for use with the enclosed syringe only. The product is tamper evident; do not use if the printed seal over the cap is broken or missing. It is important to retain the carton for future reference on full labeling.

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, 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 does not contain complete directions or warnings for adult use. Healthcare professionals should advise caregivers to adhere strictly to the dosing guidelines provided and to avoid exceeding the recommended dosage.

Before administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart, which is based on the child's weight. If weight is not available, age may be used as a secondary reference.

To administer the dose, caregivers should remove the child protective cap and carefully squeeze the prescribed amount into the dosing cup. The maximum dosage should not exceed five doses within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb or under 2 years of age, caregivers should consult a doctor for the appropriate dose.

  • For children weighing 24 – 35 lb or aged 2 – 3 years, the recommended dose is 5 mL.

  • For children weighing 36 – 47 lb or aged 4 – 5 years, the recommended dose is 7.5 mL.

  • For children weighing 48 – 59 lb or aged 6 – 8 years, the recommended dose is 10 mL.

  • For children weighing 60 – 71 lb or aged 9 – 10 years, the recommended dose is 12.5 mL.

  • For children weighing 72 – 95 lb or aged 11 years, the recommended dose is 15 mL.

It is important to note that the dose may also be directed by a healthcare professional. Caregivers should be reminded not to exceed the maximum dosage to prevent the risk of overdose.

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. Healthcare professionals should verify the presence of acetaminophen in other medications if there is uncertainty.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen can significantly increase the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to consult a doctor or pharmacist. Additionally, this product is contraindicated in children with known allergies to acetaminophen or any of the inactive ingredients.

Before administering this product, healthcare professionals should inquire whether the child has a history of liver disease. Furthermore, consultation with a doctor or pharmacist is warranted if the child is currently taking the anticoagulant warfarin.

While using this product, it is crucial to adhere to the recommended dosage to avoid overdose. Caregivers should be instructed to stop use and seek medical advice if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms develop, or if redness or swelling occurs, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is essential. Caregivers should be advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently 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.

In cases of severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

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.

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

Patients are advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

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 and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. 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 Fast Acting (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fast Acting.
Details

Pediatric Use

Pediatric patients require careful dosing and monitoring when using this product, which contains acetaminophen. The recommended dosages based on weight and age are as follows: for children under 24 pounds or under 2 years of age, consultation with a doctor is advised. For those weighing 24 to 35 pounds (ages 2 to 3 years), the dose is 5 mL; for 36 to 47 pounds (ages 4 to 5 years), the dose is 7.5 mL; for 48 to 59 pounds (ages 6 to 8 years), the dose is 10 mL; for 60 to 71 pounds (ages 9 to 10 years), the dose is 12.5 mL; and for children weighing 72 to 95 pounds (age 11 years), the dose is 15 mL.

Healthcare professionals should be aware of the potential for severe liver damage if a child exceeds 5 doses in a 24-hour period, which is the maximum daily amount. It is crucial to 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, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both children and adults, even if no signs or symptoms are present.

Dosing should be based on the child's weight; if weight is not available, age may be used as a guide. It is important to use only the enclosed dosing cup specifically designed for this product and to adhere strictly to the dosing instructions to avoid overdose.

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. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this population. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of geriatric patients.

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

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 5 doses within a 24-hour period is exceeded. Additionally, caution is advised when administering this product alongside other medications that also contain acetaminophen, as this may further increase the risk of liver injury. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the amount ingested and the individual’s health status. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs. The healthcare provider should be 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 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 to keep this medication out of reach of children to prevent accidental ingestion. It is crucial 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 about the presence of acetaminophen in other medications, 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 contained 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 new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is important to emphasize that patients must not exceed the recommended dosage, and they should be made aware of the overdose warning associated with this product. Additionally, healthcare providers should recommend that patients consult a doctor before using this medication if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Fast Acting, 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 Fast Acting, 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

Last AI update:

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.