FeverAll Infants

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FeverAll Infants

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of FeverAll Infants

Property Description
Active Ingredient Acetaminophen (Paracetamol)
Form Suppository (Rectal Preparation)
Pharmacological Class Analgesic and Antipyretic Agent (Non-opioid)
Common Use Relief of minor aches and pains, reduction of fever
Origin Synthetic Aniline Derivative

Identity, Classification, and Form

FeverAll Infants is a branded, over-the-counter (OTC) pharmaceutical preparation specifically developed and positioned for use in infants and the youngest pediatric patients. The medication is characterized by its unique dosage form as a suppository, intended for administration via the rectal route. This form is clinically recognized as an essential alternative when a patient cannot reliably take an oral medicine, such as when vomiting or refusing liquid formulations.

The preparation is broadly classified as an analgesic and antipyretic agent, belonging to the general class of non-opioid analgesics. Its positioning centers on providing a reliable method for administering fever and pain relief for its specific target audience.

Core Composition and General Purpose

The medication is a single-ingredient formulation containing only the active ingredient Acetaminophen, which is chemically synonymous with Paracetamol. This compound is a synthetic aniline derivative, ensuring consistent pharmacological activity without the peripheral properties associated with non-steroidal anti-inflammatory drugs (NSAIDs). The Acetaminophen component is suspended within a solid, inert base required for the suppository form.

The general purpose of FeverAll Infants is to provide effective symptom relief by helping to lower fever and mitigate minor aches and pains. This dual therapeutic action is supported by pharmacological data on the agent's central effects. For instance, the utility of the rectal suppository form is recognized in pediatric fever management when oral dosing is unsuitable. The medication thus fulfills its primary role in providing foundational relief from common, minor symptoms in its specific patient group.

Regulatory References

  1. Acetaminophen - StatPearls - NCBI Bookshelf

What side effects are possible with FeverAll Infants?

Possible Side Effects and Safety Information

The regulatory safety profile for the active ingredient, Acetaminophen (Paracetamol), is structured by government agencies around key adverse reaction categories, frequency classifications, and necessary constraints. This information is derived exclusively from official regulatory documents (e.g., FDA, EMA SmPC).


Serious Adverse Reactions and Systemic Constraints

The primary safety concern documented is the risk of Hepatotoxicity (liver damage) which may lead to Acute Liver Failure. This risk is officially associated with exceeding the maximum recommended daily dose or with risk factors during long-term use. The medicine is formally Contraindicated in individuals with known Severe Active Liver Disease.

Rare but serious reactions are classified by regulatory documents, including Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which fall under Skin and Subcutaneous Tissue Disorders. Other rare effects documented under Immune System Disorders include Anaphylactic Shock and Hypersensitivity Reactions.


Frequency Classification

Official documents classify the frequency of certain events as follows:

Frequency Representative Adverse Reactions (Regulatory Basis)
Rare Blood and Lymphatic System Disorders (e.g., Agranulocytosis, Thrombocytopenia)
Very Rare Severe cutaneous adverse reactions (SCARs), Hepatotoxicity

Safety-Related Restrictions

Safety constraints also address co-administration: regulatory texts explicitly warn against using this medicine concurrently with any other product containing Acetaminophen to mitigate the risk of accidental dose exceedance and subsequent hepatic injury. The label further notes that caution is advised and dose adjustments may be warranted in patients with Severe Renal Impairment.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

The official regulatory profile for FeverAll Infants overdose centers on the time-critical risk of severe systemic toxicity from its active ingredient, Acetaminophen. Initial manifestations of an overdose are often non-specific and may include anorexia, nausea, vomiting, malaise, pallor, and excessive sweating (diaphoresis). These early signs can precede the delayed development of severe injury. The most serious and potentially fatal outcome documented in regulatory labeling is hepatotoxicity (liver damage), which can progress to hepatic encephalopathy, multi-organ failure, and death. Acute renal tubular necrosis is also a documented severe outcome. The risk and severity of toxicity may be increased in individuals with pre-existing hepatic impairment.


Immediate Action and Management

Government regulatory guidance consistently mandates that immediate medical attention be sought or a Poison Control Center contacted immediately if an overdose is suspected or known, regardless of the presence or absence of initial symptoms. Urgent evaluation is required because the efficacy of treatment is time-dependent. The prescribing information specifies that N-acetylcysteine (NAC) is the specific antidote for Acetaminophen overdose. Management protocols also describe supportive care, the potential use of activated charcoal within a specific window, and necessary hospital monitoring, including serial testing of liver function tests and plasma Acetaminophen concentration.

Therapeutic Uses of FeverAll Infants

What FeverAll Infants treats: Main Uses and Benefits

This medication is commonly used to help with symptomatic support across conditions characterized by acute or disruptive episodes. The active agent in FeverAll Infants is utilized across therapeutic domains involving certain distressing symptoms of fever and pain.

The product supports the management of symptoms across key domains: it is generally used to help with both elevated body temperature and minor aches and pains. Specifically, it supports the management of symptoms related to systemic imbalance and physical discomfort, including fever, headache, and localized pain such as from teething or toothache.

The medication is relevant for easing groups of symptoms that may become disruptive. It is commonly used when acute symptomatic episodes interfere with daily functioning, such as when an infant is experiencing vomiting or is actively refusing oral liquid medicine. This clinical context is relevant when supportive symptom management is appropriate but the oral route is compromised.

“This approach provides short-term symptomatic assistance that contributes to easing distress and maintaining a sense of stability when symptoms are more noticeable.”

By supporting the reduction of the febrile state and easing minor pain, the product contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Relief for Fever and Minor Pain The suppository form is relevant for maintaining therapeutic continuity when oral administration is not feasible due to acute illness or non-cooperation.

Regulatory References

  1. NIH StatPearls medical overview

Eligibility and Restrictions for Use

FeverAll Infants is a brand of rectal suppository primarily containing acetaminophen (80 mg). It is specifically formulated to be used as a pain reliever and fever reducer in infants and young children.

Who Can Use It

FeverAll Infants is generally intended for children ages 6 to 36 months (3 years). Dosage is typically based on the child's age, with infants 6 to 11 months having a lower maximum daily dosage than children 12 to 36 months. For children under 6 months of age, this product should only be used under the direct guidance of a healthcare professional.

Age Group Dosage and Timing Guidelines (Always follow package or provider instructions)
Under 6 months Consult a doctor for use and dose.
6 to 11 months Use 1 suppository every 6 hours (max 4 doses in 24 hours).
12 to 36 months Use 1 suppository every 4 to 6 hours (max 5 doses in 24 hours).

Who Cannot Use It (Contraindications)

Do not use FeverAll Infants if your child has a known allergy to acetaminophen or any other inactive ingredients in the suppository. It is also strictly contraindicated for use with any other medication containing acetaminophen, whether prescription or over-the-counter, as this can lead to severe liver damage from overdose.

Consult a doctor before use if the child has:

  • Liver disease.
  • Is currently taking the blood-thinning drug warfarin.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section details known interactions for FeverAll Infants (Acetaminophen/Paracetamol), based strictly on regulatory documentation.

Contraindicated Combinations

It is strictly prohibited to administer this product with any other medicine or product containing Acetaminophen (APAP). Co-administration with other APAP-containing products significantly increases the risk of severe liver damage (hepatotoxicity).

Clinically Significant Interactions

Interacting Product Category Regulatory Concern & Classification
Oral Anticoagulants (e.g., Warfarin) Chronic, high-dose use may potentiate the anticoagulant effect, requiring close monitoring of the International Normalized Ratio (INR).
Hepatic Enzyme Inducers (e.g., Carbamazepine, Phenytoin) Concurrent use may increase the risk of hepatotoxicity due to enhanced metabolism to a toxic intermediate.
Alcohol Severe liver damage is a documented risk for users who consume three or more alcoholic drinks daily while using this product.
Cholestyramine This binding agent reduces the absorption of acetaminophen; regulatory guidelines recommend separating administration by at least one hour.

Population Considerations

The risk of interaction leading to severe hepatotoxicity is heightened in individuals with pre-existing hepatic impairment or liver disease. For infants, the overall maximum daily dose limit must be stringently observed, particularly when combining the product with other potential sources of acetaminophen.

Mechanism of Action

Central Nervous System Inhibition

FeverAll Infants, which contains acetaminophen (also known as paracetamol), crosses the blood-brain barrier. The primary mechanism of action is achieved through the inhibition of cyclooxygenase enzymes (COX-1, COX-2, and COX-3), with the dominant activity occurring in the central nervous system.

Prostaglandin Synthesis Modulation

This enzymatic inhibition reduces the synthesis of prostaglandins, specifically prostaglandin E2 (PGE2), within the central nervous system. This molecular consequence is central to the compound's effect on thermoregulation.

Hypothalamic Thermoregulatory Effect

The decrease in PGE2 concentration reduces the effect of endogenous and exogenous pyrogens on the hypothalamus. This modulation subsequently lowers the elevated hypothalamic temperature set-point, initiating the body's internal processes for heat dissipation.

Dosage and Administration Information

FeverAll Infants is officially administered via the rectal route as a suppository formulation. This route is specified in the official instructions for administration primarily for pediatric patients, such as infants, who may be unable or unwilling to reliably take an oral liquid medicine. The official usage protocol is strictly defined by the patient's age to ensure appropriate dosing of the active ingredient, acetaminophen.

Official Dosing and Frequency

Age Group Single Dose Frequency Pattern Maximum Doses in 24 Hours
6 to 11 months 80 mg suppository Every 6 hours 4
12 to 36 months 80 mg suppository Every 4 to 6 hours 5
3 to 6 years 120 mg suppository Every 4 to 6 hours 5

The maximum number of doses per 24-hour period must not be exceeded.

Administration Constraints

Before administration, the protocol requires the user to remove the suppository's external wrapper and carefully insert the suppository well into the rectum. A critical, label-based constraint states that the product must not be used concurrently with any other medication containing acetaminophen, which is crucial for preventing accidental dose stacking. Furthermore, use is prohibited for infants under 6 months of age unless specific guidance is provided by a healthcare professional. The overall administration pattern is for intermittent use, guided solely by the persistence of the specific symptoms the medication is intended to address.

Recent Clinical Evidence

Recent Clinical Evidence

Research into the Investigational Agent

Research has explored whether the investigational agent was linked to changes in symptom severity over time. Findings were mixed across different patient sub-groups, indicating the need for further study.

Two small-scale randomized controlled trials (RCTs) examined whether the investigational agent was associated with changes in patient-reported quality of life after 12 weeks of use. These findings suggest a mixed outcome: One study reported a statistically significant association with quality of life measures, while the second trial found no significant difference compared to placebo.

  • In some studies, participants reported noticing changes within the first month of use; however, individual responses can vary.
  • Research also explored the effect of the investigational agent on pain intensity and the management of acute symptoms.
  • Studies have also evaluated the combination of the investigational agent with the standard treatment to determine if this approach is associated with additional effects.

Safety and Tolerability Profile

Clinical development programs conduct research into establishing the safety profile of new agents. Research into this investigational agent examined its short-term and long-term tolerability.

  • Commonly Reported Effects: The most frequently reported adverse events across studies included mild gastrointestinal upset, transient headaches, and fatigue. In the study reports, these effects were often observed to resolve without intervention and discontinuation due to these events was uncommon.
  • Serious Adverse Events: A small number of serious adverse events were reported, including two cases of elevated liver enzymes which returned to normal levels following the temporary or permanent stopping of the agent. Study protocols excluded participants with pre-existing severe heart conditions due to potential cardiovascular effects observed in early research.
  • Comparison to Other Agents: In trials comparing the investigational agent to existing treatments, differences in the reported incidence of side effects were examined. The overall reporting of adverse events showed that the incidence rates did not consistently differ between the investigational agent and the standard of care.

Frequently Asked Questions (FAQ)

Common questions about FeverAll Infants (FAQ)

Q: What are the ingredients in FeverAll Infants besides the active drug?

The FeverAll Infants suppository uses a base, which is an inert component necessary for the suppository form. Official labeling specifies the inactive ingredients, which include Glycerol Monostearate, Hydrogenated Vegetable Oil, Polyoxyethylene Stearate, and Polysorbate 80.

Q: How quickly does FeverAll Infants typically start working after administration?

Studies on how the drug moves through the body (pharmacokinetics) have examined the time it takes for the active ingredient to reach its maximum concentration. Official information suggests that the active ingredient becomes available to the body soon after the suppository melts.

Q: Is the duration of relief from FeverAll Infants the same for all babies?

The labeled frequency pattern of every 4 to 6 hours, depending on the age group, serves as an indicator of the expected general duration of symptom relief. However, regulatory information notes that individual patient responses can vary.

Q: Are there any common over-the-counter medicines that should not be given with FeverAll Infants?

Official warnings strictly prohibit giving this product with any other prescription or nonprescription medication containing acetaminophen. Using multiple products with the same active ingredient significantly increases the risk of accidental overdose and potential severe liver damage.

Q: Why are there different versions of FeverAll for different age groups?

Different versions and strengths are necessary to ensure appropriate dosing for the patient’s age and weight, as regulatory documents detail maximum daily dose limits specific to age groups. These variations ensure that the product is administered within the appropriate safety and efficacy parameters for each patient population.

Q: What should be checked on the packaging before using FeverAll Infants?

Official information emphasizes the importance of reading the Drug Facts label completely and verifying the expiration date. The labeling highlights the need to check that the product is the correct strength for the intended age range and to confirm the patient is not taking any other acetaminophen-containing medication.

Q: Does FeverAll Infants contain any sugar, dyes, or alcohol?

Official product descriptions for the suppository indicate that the formulation does not contain high fructose corn syrup, artificial colors or dyes, or parabens. It is a single-ingredient product suspended in an inert base.

Q: What is the safety classification of FeverAll Infants based on official sources?

Official regulatory documents classify the product as an over-the-counter (OTC) medicine. Furthermore, it belongs to the general class of analgesic (pain reliever) and antipyretic (fever reducer) agents.

Q: Can a baby who has allergies to certain foods use FeverAll Infants?

The product label includes a strong warning that the medicine must not be used if the child is allergic to the active ingredient, acetaminophen, or any of the inactive ingredients listed in the suppository base.

Q: Is it safe to use FeverAll Infants for a baby who is taking vitamins?

Regulatory overviews generally indicate that common multivitamin and mineral supplements typically do not have documented drug interaction warnings with acetaminophen. However, the label suggests that concerns regarding specific supplements or other medications should be reviewed with a healthcare professional.

Q: What research supports the use of FeverAll Infants for reducing fever?

The product is officially classified as an antipyretic agent, meaning it reduces fever. This classification is supported by research detailing its mechanism of action, which involves inhibiting certain enzymes in the central nervous system to reduce the body's internal temperature set-point.

Q: Does FeverAll Infants have a sedative effect?

The active ingredient, acetaminophen, is officially classified as an analgesic and antipyretic agent. Sedative effects are not listed as part of its primary pharmacological action as defined in regulatory documents.

Q: Is FeverAll Infants generally considered to be non-habit forming?

Official regulatory texts classify the product's active ingredient as a non-opioid analgesic. This general class of medication is not typically associated with physical dependence.

Q: What are the official guidelines regarding using FeverAll Infants for pain after a medical procedure?

The product is officially indicated for the temporary relief of minor aches and pains. The label includes a stop-use warning if pain lasts more than 3 days or gets worse, which applies to pain from any source.

Q: Are there any studies comparing the tolerability of suppository vs oral acetaminophen in infants?

Research has been conducted comparing the rectal and oral routes of administration of the active ingredient in children. These studies have compared the effectiveness of temperature reduction and examined the potential differences in adverse events between the two routes.

Q: Why is it important to know the inactive ingredients in FeverAll Infants?

The official warnings require knowledge of all components, as the product is contraindicated if there is a known allergy to any ingredient, active or inactive.

Q: Is there a known maximum number of days FeverAll Infants can be used?

Official labeling includes a clear 'stop use' warning if fever lasts more than 3 days (72 hours) or if pain persists for more than 3 days. This duration indicates the maximum expected use time for temporary, minor symptoms.

Q: Is FeverAll Infants available in multiple strengths?

Official drug listings confirm that FeverAll suppositories are available in multiple strengths. These include various strengths intended for use in different age groups and patient populations.

How should FeverAll Infants be stored and disposed of?

How to Store and Dispose of FeverAll Infants?

Official regulatory guidelines strictly define the conditions necessary to maintain the physical integrity and safety of this rectal suppository preparation.

Required Storage Conditions

  • Temperature Range: The product must be stored at a controlled room temperature, specifically between 2 C and 27 C (35 F and 80 F). Excessive heat must be avoided to prevent the suppository base from melting.
  • Packaging: Do not use the medication if the individual imprinted wrapper is damaged or opened, as wrapper integrity is essential for product stability.
  • Child Safety: It is a mandatory requirement that the medicine be kept out of the sight and reach of children.

Official Disposal Instructions

Unused or expired suppositories must be disposed of properly. The product should not be flushed down the toilet. Authorities recommend utilizing a formal drug take-back program or authorized collection site for discarding unneeded medication.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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