Maxtra COLD

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Maxtra COLD

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Maxtra COLD

Quick Facts: Maxtra COLD

Property Description
Active Ingredients Caffeine, Cetirizine, Nimesulide, Paracetamol, Phenylephrine
Form Tablet
Pharmacological Class Combination Analgesic, NSAID, Antihistamine, CNS Stimulant
Common Use Symptomatic relief of cold and flu manifestations
Origin Synthetic Compound (Fixed-Dose Combination)

Maxtra COLD: Definition and Pharmacological Classification

Maxtra COLD is a proprietary Fixed-Dose Combination (FDC) drug, a synthetic compound administered as a tablet via the oral route, designed to provide comprehensive symptomatic relief for acute discomfort. It is classified as a multi-action pharmaceutical that integrates the activities of an analgesic, antipyretic, antihistamine, non-steroidal anti-inflammatory drug (NSAID), and a central nervous system (CNS) stimulant. This specific FDC composition, which includes the NSAID Nimesulide, sets it apart from more common cold preparations that rely solely on Paracetamol for fever reduction.

Composition and Multi-Entity Formulation

The medicine's efficacy is based on the specific blend of five essential active ingredients: Caffeine, the second-generation antihistamine Cetirizine, Nimesulide, Paracetamol (or N-acetyl-p-aminophenol), and Phenylephrine. Phenylephrine is classified as a sympathomimetic agent and nasal decongestant. The choice of Cetirizine further distinguishes the formula, as it is associated with a lower potential for drowsiness compared to first-generation antihistamines. This is a key consideration for patients seeking symptomatic relief during the day. The tablet utilizes standard pharmaceutical excipients necessary for the stability and manufacturing of the solid oral dosage form.

General Purpose and Benefit for Symptomatic Relief

The overall therapeutic purpose of this formulation is the integrated management of discomfort associated with upper respiratory tract infections. The combination of agents simultaneously works to reduce fever, diminish pain, relieve nasal congestion via blood vessel constriction, and control allergic manifestations. The inclusion of Caffeine, a mild CNS stimulant, helps counteract the fatigue and malaise often reported by patients, providing both physical comfort and an improved sense of alertness during recovery.

Regulatory References

  1. Acetaminophen - StatPearls - NCBI Bookshelf
  2. Cetirizine - StatPearls - NCBI Bookshelf
  3. FDA Advisory Panel Rules that Oral Phenylephrine Is Ineffective - AAFP

What side effects are possible with Maxtra COLD?

Possible Side Effects and Safety Information

The safety profile of this medicine is based on the documented adverse reactions of its five active components, with reported effects categorized across multiple physiological systems in official regulatory documents. Safety classifications regarding frequency are derived from product labels, which generally include categories such as common, uncommon, rare, and very rare.


System-Organ Class Safety Patterns

Adverse effects are grouped into System-Organ Classes (SOCs) according to regulatory standards:

  • Hepatobiliary System Disorders: A primary concern is the risk of severe hepatic reactions and acute liver failure due to the Paracetamol and Nimesulide components. Very rare fatal cases of liver injury have been associated with Nimesulide. Liver damage has been documented following short exposure to the medication.
  • Gastrointestinal System Disorders: The NSAID component carries a documented risk of serious events including gastrointestinal bleeding, ulceration, or perforation. Common effects include nausea, diarrhoea, and abdominal pain.
  • Nervous System Disorders: Common effects include drowsiness and headache (from Cetirizine), and insomnia or nervousness (from Caffeine and Phenylephrine).
  • Cardiac and Vascular Disorders: The sympathomimetic agent may lead to tachycardia, palpitations, and increased blood pressure.

Serious and Population-Specific Safety Considerations

The medicine is associated with the possibility of serious skin reactions (e.g., Stevens-Johnson syndrome), which are most likely to occur early in the course of therapy. Older adults are documented to have an increased risk and severity of adverse reactions, particularly involving the GI tract. Use is generally restricted or requires caution in individuals with pre-existing hepatic or renal impairment, as well as during pregnancy or breastfeeding, based on official label constraints.

Overdose and Emergency Response

Overdose and When to Seek Help

Urgent medical advice must be sought immediately in the event of any suspected overdose of Maxtra COLD, even if the patient feels well. This is a critical requirement due to the high risk of delayed, serious liver damage associated with the Paracetamol component.

Clinical Manifestations Documented in Overdose
Early: Pallor, nausea, vomiting, abdominal pain (may be mild or absent initially).
CNS: Restlessness, excitement, insomnia, tremor, delirium, somnolence, and convulsions.
Cardiovascular: Tachycardia (rapid heart rate), hypertension (high blood pressure), and reflex bradycardia (slow heart rate).
Severe Outcomes: Hepatic failure, hepatic encephalopathy, haemorrhage, cardio-respiratory collapse, and coma.

Regulator-Mandated Emergency Actions:

  1. Seek Immediate Medical Attention: Contact a Poison Centre or proceed to the nearest emergency department promptly for urgent assessment.
  2. Antidote: N-acetylcysteine (NAC) is the specific antidote for Paracetamol toxicity and must be administered according to specific hospital protocols. Timely administration is essential to prevent liver damage.
  3. Supportive Management: Hospital monitoring, including measurement of plasma Paracetamol concentration and cardiac monitoring, is required. Symptomatic and supportive treatment is necessary to manage non-Paracetamol effects (e.g., CNS and CVS effects).

Population Considerations: Individuals with risk factors such as concurrent use of enzyme-inducing drugs or non-cirrhotic alcoholic liver disease have a greater hazard of severe hepatic toxicity. In children, CNS stimulation may be prominent in overdose.

Therapeutic Uses of Maxtra COLD

What Maxtra COLD Treats: Main Uses and Benefits

This medication is generally applied in contexts where additional symptomatic support is needed for acute or disruptive symptom patterns, and may help patients cope more steadily with symptom fluctuations. It is commonly used for conditions characterized by periods of heightened symptoms associated with colds, flu, and allergies.

The product is applied in addressing symptom clusters that may become intense or disruptive, including nasal and sinus congestion, general body aches and headache, and manifestations of allergic or irritative states like a runny nose and sneezing.

In clinical scenarios involving these combined manifestations, the product may provide supportive relief that assists with maintaining functional stability when symptoms interfere with routine activities. The combination may also be relevant for easing symptoms related to systemic imbalance, including elevated body temperature.


Quick Fact: Symptomatic Relief for Stuffy Nose and Sinus Pressure

The medication may provide supportive relief that contributes to easing the symptom load associated with breathing difficulty, and assists with maintaining functional stability when symptoms are more noticeable.

Regulatory References

  1. NIH DailyMed drug label information

Eligibility and Restrictions for Use

Who can and cannot use Maxtra COLD

The eligibility for Maxtra COLD, a fixed-dose combination, is determined by the strictest restrictions of its active components, as defined in official regulatory documents. Use is contraindicated (absolutely prohibited) for several populations.


Absolute Contraindications

Maxtra COLD must not be used by children under 12 years of age. It is also contraindicated for women in the third trimester of pregnancy and those who are breastfeeding. Absolute prohibitions exist for patients diagnosed with severe hepatic impairment, severe heart failure, severe renal impairment (creatinine clearance less than 30 ml/min), active gastric or duodenal ulcers, or severe coagulation disorders. Patients taking or having recently taken a Monoamine Oxidase (MAO) inhibitor within 14 days are also contraindicated.


Conditional Use and Restrictions

Use is generally not recommended for women attempting to conceive or during the first and second trimesters of pregnancy. For the elderly and patients with conditions such as uncontrolled hypertension, mild-to-moderate renal impairment, or a history of gastrointestinal disorders, the medicine may only be used with regulatory caution. Official restrictions also apply against use in patients presenting with fever and/or flu-like symptoms due to a specific regulatory constraint on one of the active components.

What should I know about interactions with other medicines?

Maxtra COLD is a fixed-dose combination product whose interaction profile is determined by its active ingredients: Caffeine, Cetirizine, Nimesulide, Paracetamol, and Phenylephrine. Official regulatory documentation details specific substance co-administration restrictions and required precautions.

Contraindicated Combinations and Constraints

Classification Interacting Agents Constraint Detail
Prohibited Combination Monoamine Oxidase Inhibitors (MAOIs) Must not be taken if the patient has used an MAOI within the preceding 14 days [2.2].
High-Risk Combination Anti-coagulants (e.g., Warfarin) Prohibited in patients with severe coagulation disorders due to enhanced bleeding risk [4.4].
Hypersensitivity Rule Aspirin / other NSAIDs Contraindicated in individuals with a known history of hypersensitivity reactions to these substances [4.2].

Pharmacodynamic and Pharmacokinetic Interactions

Co-administration with Alcohol or other CNS Depressants (such as sedatives) is associated with an officially documented additive CNS depressant effect due to the Cetirizine component [3.3]. The Phenylephrine component may reduce the efficacy of Antihypertensive Drugs, including Beta-blockers, and its own effects may be potentiated by Tricyclic Antidepressants [1.5].

Regarding drug levels, the regulatory label notes that co-administration with Theophylline (at 400 mg/day) results in a 16% decrease in Cetirizine clearance [3.2]. The Nimesulide component reduces the AUC and cumulative excretion of Furosemide [4.2].

Population-Specific Cautions

Caution is officially required when Nimesulide is combined with Diuretics, ACE Inhibitors, or Angiotensin II Antagonists in elderly patients or those with reduced renal function, due to the potential for renal deterioration [4.4].

Mechanism of Action

The mechanism involves coordinated action across three physiological domains. In the nasal mucosa, Phenylephrine acts as an Alpha-1 Adrenergic Agonist, inducing vasoconstriction and reducing mucosal volume. Concurrently, Cetirizine blocks Histamine H1 Receptors, limiting the mediator’s effect on capillary permeability and glandular activity. This results in the modulation of local fluid volume and secretory dynamics. Systemically, Nimesulide selectively inhibits the COX-2 enzyme, limiting peripheral Prostaglandin synthesis to reduce nociceptor sensitization. Paracetamol acts centrally, inhibiting Prostaglandin synthesis in the hypothalamus to adjust the thermal set-point. Finally, Caffeine operates in the CNS as an Adenosine Receptor Antagonist at the A1 and A2 A subtypes, functionally disinhibiting neural pathways. This molecular action leads to increased neuronal firing and influences physiological arousal.

Dosage and Administration Information

The administration of Maxtra COLD is governed by the constraints of its multi-component fixed-dose combination (FDC). The approved route is oral, with the medicine provided as a tablet that must be swallowed whole with water.

Standard Dosing and Frequency

The standard adult regimen involves the use of one tablet per dose. The maximum dosing frequency is restricted to four times daily (QID). This schedule involves a minimum interval of 4 to 6 hours between doses to maintain the integrity of the total daily limit of the Paracetamol component. The overall use is designated as short-term for acute symptomatic episodes and is typically limited to a maximum of 3 to 7 consecutive days.

Administration Context and Specific Populations

The product has established parameters regarding the context of intake. Due to the presence of an NSAID (Nimesulide), the tablet is advised to be taken with or immediately following food to mitigate potential gastric irritation. Furthermore, explicit parameters govern use in specific populations: Maxtra COLD is not approved for administration to children under the age of 12. For older adults or patients with documented hepatic or renal function impairment, dose adjustment or avoidance is noted as a requirement of the medication's use. The FDC nature mandates that it must not be taken with any other product containing Paracetamol.

Recent Clinical Evidence

Maxtra COLD: Recent Clinical Evidence

Evidence for Symptomatic Relief of Common Cold and Flu-like Syndrome

The research base for multi-ingredient cold and flu study interventions was studied for conditions characterized by fluctuating or episodic manifestations, such as the common cold. These studies typically utilize short-term Randomized Controlled Trials (RCTs) to compare the study intervention against a placebo. Additionally, large-scale systematic reviews examine the combined research landscape for the formulation’s core components: analgesics, antihistamines, and decongestants.

Researchers monitored outcomes related to physical discomfort using metrics like the Total Symptom Score (TSS)—a cumulative measurement of key symptoms like fever and headache. Findings describe patterns observed in the studies where composite symptom scores showed differences between the study intervention groups and placebo groups in the acute phase of illness. However, evidence is limited when considering the findings for the precise five-ingredient combination in this formulation, as the research context is often extrapolated from studies on similar three- or four-ingredient combinations.


Follow-Up Duration and Evidence Gaps

The clinical research for acute respiratory conditions is characterized by follow-up durations that were limited, typically ranging from 48 hours to around 5 days. Long-term effects are not fully established, as the focus of the existing research is on acute symptomatic change. As a result, there is limited information for long-term outcomes related to this type of study intervention.


Evidence in Study Populations and Key Limitations

Studies primarily explored groups of generally healthy adults who presented with cold or flu-like symptoms. Data for certain groups remain insufficient, including evidence for older adults or individuals with pre-existing chronic conditions. A key limitation is the comparative evidence is lacking for this precise five-ingredient FDC against a placebo or a different cold remedy in large, published RCTs. Research is ongoing to fully characterize the optimal therapeutic approach for multi-symptom cold relief. This evidence highlights what is known—and what is still uncertain—about this combination formulation.

Key Studies & References

  1. NIH DailyMed: Drug Label Information (setid=7cd8f7f3-c262-4f7c-bcaf-068be2c952f9) - Symptomatic Relief Combination
  2. Review of fixed dose combinations (FDCs) of drugs in India: an ethical perspective (Context for FDC limitations and evidence gaps)

Frequently Asked Questions (FAQ)

Common questions about Maxtra COLD (FAQ)

Q: Is Maxtra COLD an antibiotic or an antiviral?

A: According to official documents, Maxtra COLD is classified as a multi-action pharmaceutical product and a Fixed-Dose Combination (FDC). It integrates the effects of several different types of medicines, including an analgesic, an antihistamine, and a CNS stimulant. It is not classified as an antibiotic, which treats bacterial infections, nor is it an antiviral medicine.

Q: What happens if I forget to take a scheduled amount of Maxtra COLD?

A: Regulatory guidance for missed doses generally suggests that if an amount is forgotten, it can be taken when remembered. However, if it is nearly time for the next scheduled amount, the missed amount is typically skipped. This approach is intended to ensure the minimum recommended interval between doses is respected and to avoid exceeding the total daily amount of the active ingredients.

Q: Do studies suggest that Maxtra COLD is effective for relieving nasal congestion?

A: Studies examining the formulation’s core components, including the decongestant Phenylephrine, describe their purpose as contributing to the relief of nasal congestion. This component acts to reduce the volume of the nasal passages. Official research has observed patterns of symptomatic relief, although evidence is often extrapolated from similar combinations rather than focusing solely on this five-ingredient formulation.

Q: How quickly can I expect to notice the effects of Maxtra COLD?

A: The official documentation does not specify the exact time of onset for the full multi-component combination. However, one of its core components, Paracetamol (an analgesic), typically begins to work within 30 to 60 minutes after administration. Individual responses to medication may vary.

Q: What is the total expected duration of action for a single use of Maxtra COLD?

A: The recommended dosing schedule mandates a minimum interval of 4 to 6 hours between doses. This time frame is generally set to correspond with the expected duration of the therapeutic effect of the formulation's key components.

Q: Is it typical for Maxtra COLD to cause drowsiness or sleepiness?

A: Yes, regulatory materials document drowsiness as a common effect associated with the use of this medicine due to the Cetirizine component. Because this effect is common, activities requiring concentration, such as driving or operating machinery, may need to be approached with caution.

Q: Can I use Maxtra COLD if I have high blood pressure?

A: Official guidance states that caution is required for patients with pre-existing conditions such as uncontrolled hypertension (high blood pressure). The medicine's decongestant component, Phenylephrine, can also potentially affect blood pressure. The use of this medicine for individuals with hypertension requires a review of the entire medical context.

Q: Are there any specific foods or drinks that should be avoided when using Maxtra COLD?

A: Official guidance describes the need to limit the consumption of foods and beverages that contain additional caffeine. This is necessary because Caffeine is already an active ingredient in Maxtra COLD, and excessive intake could lead to additive stimulant side effects like nervousness or an increased heart rate.

Q: Is Maxtra COLD suitable for use by individuals with diabetes?

A: Official documentation for combination products containing sympathomimetic agents requires caution in patients with underlying conditions like diabetes. This is because these agents can potentially affect blood sugar levels. The use of this medicine for individuals with diabetes requires careful consideration of the medical context.

Q: What kind of side effects are commonly reported with Maxtra COLD?

A: The safety profile, based on regulatory documentation, groups adverse effects into several classes. Commonly reported effects include gastrointestinal issues such as nausea, diarrhoea, and abdominal pain. Effects on the nervous system like drowsiness, headache, insomnia, or nervousness are also frequently reported.

Q: Is it common to feel jittery or restless after using Maxtra COLD?

A: Yes, the official safety profile documents nervousness and insomnia as common effects associated with the use of this medicine. These effects may be perceived by patients as feeling 'jittery' or 'restless' and are primarily linked to the stimulant components, Caffeine and Phenylephrine.

Q: Can Maxtra COLD affect my ability to drive or operate machinery?

A: Drowsiness is a common documented effect of this medicine. If the medicine causes feelings of dizziness, sleepiness, or decreased alertness, it is advised to exercise caution with activities such as driving or operating machinery.

Q: Can I use Maxtra COLD if I am taking medicines for anxiety or depression?

A: Official documents state that the medicine is absolutely prohibited (contraindicated) if a patient has used Monoamine Oxidase Inhibitors (MAOIs) within the preceding 14 days. Furthermore, the combination may lead to an additive CNS depressant effect when taken with other sedatives. The full medication list must be considered when reviewing the use of this medicine.

Q: Is Maxtra COLD known to cause rebound congestion if used for too long?

A: Regulatory guidance restricts the overall use of the product to short-term symptomatic relief, typically limiting its use to a maximum of 3 to 7 consecutive days. This short-term limit is a necessary constraint for decongestant-containing products to manage risks associated with prolonged use.

Q: Is Maxtra COLD safe for use during pregnancy, according to official guidance?

A: Official guidance for this medicine states that it is contraindicated (prohibited) for women in the third trimester of pregnancy. Furthermore, its use is generally not recommended during the first and second trimesters of pregnancy. The decision to use this medicine during pregnancy requires professional assessment.

Q: Can Maxtra COLD interact with herbal supplements?

A: Official warnings for the stimulant components advise limiting the intake of external caffeine sources, which can include certain herbal supplements. This precaution is advised due to the potential for enhanced side effects when combined with the caffeine already present in the medicine.

Q: Does taking Maxtra COLD on an empty stomach change its effect?

A: Official administration guidance advises taking the tablet with or immediately following food. This is recommended because of the presence of the NSAID component. The recommendation to take it with food is intended to mitigate the potential for gastric irritation.

Q: Is it possible to become dependent on Maxtra COLD?

A: This multi-component product is not typically classified as a controlled substance with a high potential for abuse. However, official warnings note the potential for psychological dependence if products with stimulants are used improperly or beyond recommended limits.

Q: Are there any known interactions between Maxtra COLD and caffeine?

A: Yes, official warnings advise limiting the consumption of external sources of caffeine, such as coffee, tea, or cola. Since Caffeine is an active ingredient in Maxtra COLD, combining it with additional external caffeine may lead to additive stimulant effects, such as increased heart rate or nervousness.

Q: Is Maxtra COLD generally considered suitable for older adults?

A: Official documents state that older adults are documented to have an increased risk and potential severity of adverse reactions, particularly involving the GI tract. Therefore, the medicine should be used with caution in this population, and dose adjustment or avoidance is a necessary consideration.

Q: What should I do if I experience a rash after taking Maxtra COLD?

A: The medicine is associated with the possibility of serious skin reactions, which are most likely to occur early in the course of therapy. If a rash or any signs of a severe allergic reaction occur, official guidance indicates that medical attention is required immediately.

Q: What is the risk of overdose with Maxtra COLD?

A: Maxtra COLD carries a serious risk of severe hepatic reactions and acute liver failure, primarily due to the Paracetamol and Nimesulide components. Official information emphasizes that overdose is a serious medical emergency.

Q: Is there any research comparing Maxtra COLD to single-ingredient cold remedies?

A: The existing research base is often extrapolated from studies on similar three- or four-ingredient cold combinations. Comparative evidence for this precise five-ingredient formulation against a single-ingredient remedy in large published trials is limited, with studies mainly comparing the FDC against a placebo.

Q: Are there different formulations or strengths of Maxtra COLD available?

A: Official documents define this specific product as a Fixed-Dose Combination (FDC) tablet with a fixed composition. While similar products may exist, this particular FDC product is defined solely by its prescribed composition as a tablet.

Q: Why do some people experience dry mouth when taking Maxtra COLD?

A: Dry mouth is a common effect associated with the use of the antihistamine component, Cetirizine, which is included in this medicine. The purpose of this component is to limit glandular activity and control local fluid volume in the nasal area, which can contribute to the feeling of dry mouth.

Q: Can Maxtra COLD cause stomach upset?

A: Yes, common gastrointestinal effects are documented in official labeling. These include the general discomfort referred to as 'stomach upset,' as well as more specific effects like nausea, diarrhoea, and abdominal pain.

Q: Why might a person feel dizzy when using this medicine?

A: Dizziness is a commonly reported effect associated with the use of the antihistamine component (Cetirizine) present in this medicine. It is categorized as a nervous system effect in the official safety profile.

Q: What are the non-medicinal ingredients in Maxtra COLD tablets/syrup?

A: Official regulatory information notes that the tablet utilizes standard pharmaceutical excipients—the non-medicinal ingredients—that are necessary for the stability and manufacturing of the solid oral dosage form. A complete, detailed list of every excipient is typically found in the full patient information leaflet.

Q: Do official documents mention any effects of Maxtra COLD on blood sugar levels?

A: Official documentation for combination products containing sympathomimetic agents requires caution in patients with underlying conditions such as diabetes. This is because these agents can potentially affect blood sugar levels. The use of this medicine requires careful consideration within the medical context.

Q: Is Maxtra COLD a controlled substance?

A: Based on its composition as a multi-component product that includes a CNS stimulant and a sympathomimetic agent, Maxtra COLD is typically not classified as a controlled substance under regulatory scheduling in most jurisdictions.

Q: Is Maxtra COLD a prescription-only medicine or available over-the-counter?

A: Products containing this combination of ingredients are widely available as over-the-counter (OTC) medicines for symptomatic cold relief. This is supported by the context of its regulatory documentation, which focuses on patient information and non-prescription use constraints.

Q: Is there an official statement on the use of Maxtra COLD in patients with glaucoma?

A: Official warnings for products containing the decongestant component (Phenylephrine) generally include a contraindication or strict warning against use in patients with narrow-angle glaucoma. This is due to the potential risk of exacerbating the condition.

Q: Is it necessary to finish the entire package of Maxtra COLD if my symptoms improve?

A: The medicine is designated for short-term, acute use. The overall use is typically limited to a maximum of 3 to 7 consecutive days for symptomatic episodes. If the symptoms for which the medicine was taken have resolved, official guidance does not mandate finishing the entire package.

Q: What is the relationship between Maxtra COLD and allergy symptoms?

A: Maxtra COLD contains Cetirizine, which is an antihistamine known to block histamine receptors. This action is incorporated into the formulation to help control allergic manifestations associated with cold and flu symptoms, such as sneezing or runny nose.

How should Maxtra COLD be stored and disposed of?

Official Storage and Disposal Instructions

Maxtra COLD must be stored strictly according to official regulatory guidelines to maintain its stability and effectiveness. The product should be kept at room temperature, generally not exceeding 25 C or 30 C depending on the region's official labeling.

Storage Requirements

Condition Regulatory Rule
Temperature Do not store above the maximum temperature stated on the label.
Protection Keep in the original container to protect it from light and moisture.
Safety Keep out of the sight and reach of children.

Disposal

Do not use the medicine after the labeled expiry date. Unused or expired medication should not be flushed down the toilet or poured down a sink. Disposal should follow specific instructions on the labeling or utilize official drug take-back programs. If these are unavailable, unused tablets may be mixed with an undesirable substance, sealed in a container, and discarded in the household trash.

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

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