Symptom checker
Select audience type

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

ADD CONDITION

items per page

Acetaminophen

Last content change checked dailysee data sync status

This product has been discontinued

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 2011
Label revision date
October 26, 2011
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 2011
Label revision date
October 26, 2011
Manufacturer
Accudial Pharmaceutical, Inc.
Registration number
part343
NDC root
45014-130
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

Children's ACCU DIAL® Acetaminophen Oral Solution is a medication designed to relieve pain and reduce fever in children. It is effective for temporarily alleviating minor aches and pains associated with common conditions such as the cold, flu, headache, sore throat, and toothache. This solution is suitable for children aged 6 months to under 12 years, and it is alcohol-free, aspirin-free, and ibuprofen-free, making it a gentle option for young ones.

The active ingredient in this oral solution is similar to that found in Children's Tylenol® Oral Solution, providing a familiar and trusted choice for parents. With a pleasant cherry flavor, it is easy for children to take, helping to ensure they feel better when they need it most.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including the common cold, flu, headache, sore throat, and toothache. Additionally, it helps to temporarily reduce fever, making you feel more comfortable when you're not feeling well.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you need to give another dose, you can do so every 4 hours, but remember not to exceed 5 doses in a 24-hour period. To find the right amount for your child, it’s best to use their weight. You can do this by checking the rotating bottle label, which will guide you to the correct dose based on their weight. If you don’t know their weight, you can use the age chart on the same label.

For children under 6 months, it’s important to consult a doctor before administering any dose. For those aged 6 months to under 2 years, the dose is 2.5 mL (or ½ teaspoon). Children aged 2 to under 4 years should receive 5 mL (or 1 teaspoon), while those aged 4 to under 6 years should get 7.5 mL (or 1½ teaspoons). For kids aged 6 to under 9 years, the dose is 10 mL (or 2 teaspoons), and for those aged 9 to under 11 years, it’s 12.5 mL (or 2½ teaspoons). Finally, children aged 11 to under 12 years should take 15 mL (or 3 teaspoons). Always use the enclosed dosing syringe and adapter to measure the dose accurately; do not use any other device.

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, it's important to consult with a doctor or pharmacist. Additionally, do not use this medication if your child is allergic to acetaminophen or any of the inactive ingredients in the product.

It's crucial to follow the dosing instructions carefully and not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

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. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it's important to consult a doctor immediately.

Additionally, you should not use 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, is under 6 months old or weighs less than 12 pounds, or is over 12 years old or weighs more than 95 pounds. If your child is taking the blood thinner warfarin, consult a doctor or pharmacist before use. If symptoms worsen or new symptoms appear, or if pain or fever lasts longer than specified, stop use and seek medical advice. In case of overdose, which can cause liver damage, seek medical help right away.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications that also contain acetaminophen. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it’s important to consult a doctor right away.

Be cautious and do not use this medication with any other acetaminophen-containing products. If your child has liver disease, is under 6 months old or weighs less than 12 pounds, or is over 12 years old or weighs more than 95 pounds, consult a doctor before use. Additionally, if your child is taking the blood thinner warfarin, check with a doctor or pharmacist first. Always follow the dosing instructions carefully and do not exceed the recommended amount.

If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if there are no noticeable symptoms. Stop using the medication and call your doctor 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, as these may indicate a serious condition.

Overdose

Taking more than the recommended dose of a medication can lead to serious health issues, including liver damage. If you suspect an overdose, it’s important to seek medical help immediately, even if you don’t notice any symptoms. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Remember, acting quickly is crucial in these situations. Don’t wait for symptoms to appear; getting prompt medical attention can make a significant difference in your health outcomes.

Pregnancy Use

When it comes to using Acetaminophen Oral Solution during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the drug insert does not provide guidance on how this medication may affect you or your baby during pregnancy.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking any medication, including Acetaminophen. They can help you weigh the benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of acetaminophen while nursing. This means that, based on the information available, it is generally considered safe for you to use acetaminophen without special precautions related to breastfeeding.

However, as always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about medications while nursing. They can provide personalized advice based on your individual situation.

Pediatric Use

Before giving this medication to your child, it's important to consult with a doctor if your child is under 6 months old or weighs less than 12 pounds, or if they are over 12 years old or weigh more than 95 pounds. The appropriate dosage varies by age, so here’s a quick guide: for children aged 6 months to under 2 years, the dose is 2.5 mL (½ teaspoon); for ages 2 to under 4 years, it's 5 mL (1 teaspoon); for ages 4 to under 6 years, it's 7.5 mL (1½ teaspoons); for ages 6 to under 9 years, it's 10 mL (2 teaspoons); for ages 9 to under 11 years, it's 12.5 mL (2½ teaspoons); and for ages 11 to under 12 years, it's 15 mL (3 teaspoons) or as directed by a doctor.

Always keep this medication out of reach of children, and be aware that taking more than the recommended dose can lead to serious liver damage. If an overdose occurs, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each individual may respond differently to treatments. Since the insert does not provide any recommended age considerations, dosage adjustments, or safety concerns for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your unique health needs and 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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this medication. Taking more than the recommended dose can lead to serious liver damage. Specifically, if your child takes more than 5 doses within a 24-hour period, which is the maximum allowed, there is a risk of severe liver damage. Additionally, be cautious about combining this medication with other products that contain acetaminophen, as this can also increase the risk of liver harm. Always follow dosing guidelines carefully to protect your child's liver health.

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 drug. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid potential interactions.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness.

Before using the product, check the foil seal over the mouth of the bottle. If it is torn, broken, or missing, do not use the product, as this could compromise its safety and effectiveness. Always handle the product with care to ensure it remains in good condition.

Additional Information

You should take this medication orally and remember to shake it well before each use. If necessary, you can repeat the dose every four hours, but do not exceed five doses in a 24-hour period.

Before giving this medication to your child, consult a doctor if they have liver disease, are under 6 months old or weigh less than 12 pounds, or are over 12 years old or weigh more than 95 pounds. Additionally, if your child is taking the blood-thinning medication warfarin, it's important to check with a doctor or pharmacist before use.

FAQ

What is Children's ACCU DIAL® Acetaminophen Oral Solution used for?

It is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What age group is Children's ACCU DIAL® Acetaminophen Oral Solution suitable for?

It is suitable for children aged 6 months to under 12 years or weighing 12-95 lbs.

How should I dose Children's ACCU DIAL® Acetaminophen Oral Solution?

Use the enclosed dosing syringe and adapter. The dose varies by age, for example, 2.5 mL for 6 months to under 2 years, and 15 mL for 11 to under 12 years.

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

Consult a doctor promptly if the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Are there any warnings associated with this medication?

Yes, do not use with any other drug containing acetaminophen, and avoid exceeding 5 doses in 24 hours to prevent severe liver damage.

What should I do in case of an overdose?

In the case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is it safe to use Children's ACCU DIAL® Acetaminophen Oral Solution during pregnancy or while nursing?

The provided information does not specify safety concerns or recommendations for use during pregnancy or lactation.

How should I store Children's ACCU DIAL® Acetaminophen Oral Solution?

Store it between 20°-25°C (68°-77°F) and do not use if the foil seal over the mouth of the bottle is torn, broken, or missing.

Packaging Info

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

Packaging configurations for Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's ACCU DIAL® Acetaminophen Oral Solution is a pain reliever and fever reducer formulated for children aged 6 months to under 12 years or weighing between 12 to 95 pounds. This solution is alcohol-free, aspirin-free, and ibuprofen-free, providing a safe alternative for pediatric use. The product contains acetaminophen, comparable to the active ingredient in Children's Tylenol® Oral Solution. It is presented in a cherry flavor and is packaged in a 4 fluid ounce (120 mL) bottle. Each 1/2 teaspoon (2.5 mL) delivers 80 mg of acetaminophen, equating to 160 mg per 5 mL. The National Drug Code (NDC) for this product is 45014-130-04.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Shake the product well before use. For dosing, if the child's weight is known, healthcare professionals should refer to the rotating bottle label to determine the appropriate dose based on the child's weight. This method provides the most accurate dosing. In cases where the child's weight is unknown, the age chart on the rotating label should be utilized.

The recommended dosages are as follows:

  • For children under 6 months of age, consultation with a doctor is advised.

  • For children aged 6 months to under 2 years, the recommended dose is 2.5 mL (½ teaspoon).

  • For children aged 2 to under 4 years, the recommended dose is 5 mL (1 teaspoon).

  • For children aged 4 to under 6 years, the recommended dose is 7.5 mL (1½ teaspoons).

  • For children aged 6 to under 9 years, the recommended dose is 10 mL (2 teaspoons).

  • For children aged 9 to under 11 years, the recommended dose is 12.5 mL (2½ teaspoons).

  • For children aged 11 to under 12 years, the recommended dose is 15 mL (3 teaspoons).

  • Dosing may also be adjusted as directed by a healthcare professional.

Doses may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period. It is imperative to use only the enclosed dosing syringe and adapter for administering this product; other dosing devices should not be utilized.

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 present in this formulation.

  • Exceeding the recommended dosage is contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds the maximum daily dosage of 5 doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise parents to monitor the total intake of acetaminophen from all sources to prevent potential overdose.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious condition that requires medical evaluation.

General precautions should be observed when administering this product. It is contraindicated to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, healthcare providers should be consulted. Additionally, it is advisable to seek medical advice before use if the child has a history of liver disease, is under 6 months of age or weighs less than 12 lbs, or is over 12 years of age or weighs more than 95 lbs. Caution is also warranted if the child is concurrently taking warfarin, a blood-thinning medication; consultation with a doctor or pharmacist is recommended in such cases. The dosage should not exceed the recommended amount.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial, even if no signs or symptoms are initially apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed. These may be indicative of a serious underlying condition that necessitates further investigation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is more than 5 doses within a 24-hour period, or who use this product in conjunction with other medications containing acetaminophen. Patients should be advised to avoid using this product alongside any other acetaminophen-containing drugs, whether prescription or nonprescription, and to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

In clinical observations, it is important to note that if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should seek medical attention promptly.

Patients with a history of liver disease should consult a healthcare provider before using this product. Additionally, it is recommended that parents or guardians consult a doctor before administering this medication to children under 6 months of age or weighing less than 12 lbs, as well as to those over 12 years of age or weighing more than 95 lbs.

While using this product, patients must adhere strictly to the recommended dosage and should discontinue use and consult a healthcare professional if pain worsens or lasts longer than 5 days, if fever worsens or persists beyond 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222. Prompt medical attention is critical, even if no signs or symptoms of overdose are initially 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Packaging configurations for Acetaminophen.
Details

Pediatric Use

Pediatric patients under 6 months of age or weighing less than 12 lbs should consult a healthcare professional before use. For those aged 6 months to under 2 years, the recommended dose is 2.5 mL (½ tsp). Children aged 2 to under 4 years should receive 5 mL (1 tsp), while those aged 4 to under 6 years may take 7.5 mL (1½ tsp). For children aged 6 to under 9 years, the dose is 10 mL (2 tsp), and for those aged 9 to under 11 years, 12.5 mL (2½ tsp) is recommended. Adolescents aged 11 to under 12 years may take 15 mL (3 tsp) or as directed by a healthcare professional.

This product does not provide directions or complete warnings for adult use and should be kept out of reach of children. An overdose, defined as taking more than the recommended dose, may lead to liver damage. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

There is no specific information regarding the use of Acetaminophen Oral Solution during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider before use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information. Breastfed infants are not expected to be adversely affected by maternal use of acetaminophen during breastfeeding.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data may necessitate individualized assessment and monitoring based on clinical judgment.

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 critical to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily amount. Additionally, caution is advised when considering the use of acetaminophen in conjunction with other medications that also contain acetaminophen, as this combination may further increase the risk of severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act swiftly.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center without delay, utilizing the national hotline at 1-800-222-1222 for guidance and support.

Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms. Early intervention can be vital in mitigating the risks associated with overdose and ensuring appropriate management of the patient's condition.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 containing 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 made aware of the potential for allergic reactions. They should be instructed to discontinue use and seek medical advice if their child has a known allergy to acetaminophen or any of the inactive ingredients in the product. Additionally, healthcare providers should emphasize the importance of monitoring symptoms and advise patients to stop 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 there is any redness or swelling, as these may indicate a serious condition.

It is crucial to remind patients not to exceed the recommended dosage. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease, is under 6 months of age or weighs less than 12 lbs, or is over 12 years of age or weighs more than 95 lbs. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°-25°C (68°-77°F). It is imperative that the foil seal over the mouth of the bottle remains intact; the product should not be used if the seal is torn, broken, or missing.

Additional Clinical Information

The medication is administered orally, with instructions to shake well before use. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease, is under 6 months of age or weighs less than 12 lbs, or is over 12 years of age or weighs more than 95 lbs. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

Drug Information (PDF)

This file contains official product information for Acetaminophen, 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 Acetaminophen, 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.