P & S

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Medically reviewed

Marina Burgos

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 P & S

Quick Facts

Property Description
Active ingredient Sodium Salicylate
Form Oral Solution, Tablets, Powders
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common use Pain Relief and Fever Reduction
Origin Synthetic Compound (Derived from Salicylic Acid)

The preparation known as P & S is a medication whose identity is centered on its active component, Sodium Salicylate. It is fundamentally classified as an analgesic and antipyretic agent, belonging to the Salicylate drug class, which is a subgroup of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). As a therapeutic agent, P & S is designed to exert systemic effects, meaning the medication acts internally throughout the body.

What Type of Medicine is P & S?

Sodium Salicylate is a synthetic compound, a sodium salt chemically derived from Salicylic Acid. Sodium Salicylate functions in managing mild to moderate pain and lowering body temperature, making it a clinically recognized option for foundational symptom relief. This pharmacological designation means the product functions similarly to other widely recognized pain and fever relievers by targeting the underlying causes of discomfort and inflammation.


P & S Composition and Common Forms

The active substance in the preparation is Sodium Salicylate, which is typically manufactured as a single active ingredient product. Sodium Salicylate has a recognized therapeutic role in the context of pain management.

Sodium Salicylate is formulated in several high-level dosage forms for oral administration, including tablets and oral solutions. For oral solutions, the active ingredient is dissolved or suspended within an aqueous or hydroalcoholic base; for tablets, it is combined with inert pharmaceutical excipients. This diversity in presentation ensures that the compound can be administered effectively for systemic absorption to reach the required sites within the body.


General Purpose: What Does P & S Help Achieve?

The general purpose of P & S is to provide relief from physical discomfort and facilitate the reduction of fever. By acting as both an analgesic and an antipyretic, the medication is aimed at alleviating mild to moderate pain and lowering an elevated body temperature. Its inherent anti-inflammatory characteristics further contribute to its utility by helping to mitigate swelling and localized irritation.

Regulatory References

  1. Sodium Salicylate - MeSH - NIH
  2. WHO Model List of Essential Medicines (23rd List, 2023)

What side effects are possible with P & S?

Possible Side Effects and Safety Information

P & S (Phenol and Salicylic Acid) solution is typically used topically on the scalp. While generally well-tolerated, it is essential to be aware of potential side effects, primarily associated with the active ingredients phenol and salicylic acid.

Common and Minor Side Effects

The most frequently reported side effects are localized and temporary, often due to irritation from the ingredients:

  • Skin irritation or a mild burning sensation at the application site.
  • Dryness or peeling of the skin.
  • Temporary hair discoloration, particularly on gray or light-colored hair.
  • Itching or redness.

Less Common or Serious Side Effects

Although rare, systemic absorption or allergic reactions can lead to more significant effects, which require immediate medical attention:

  • Signs of a severe allergic reaction (e.g., rash, hives, difficulty breathing, swelling of the face or throat).
  • Signs of salicylate toxicity (salicylism) from excessive absorption, which may include nausea, vomiting, dizziness, ringing in the ears (tinnitus), or headache.
Safety Consideration Key Precaution
Application Avoid contact with eyes, mucous membranes, and broken, irritated, or infected skin.
Children Consult a healthcare provider before use in children due to increased risk of salicylic acid absorption.
Drug Interactions Inform your doctor or pharmacist about all other topical medications being used.
Absorption Do not use under occlusive dressings or for prolonged periods on large areas of the body, as this increases systemic absorption.

Discontinue use and consult a healthcare professional if side effects worsen or if signs of systemic toxicity appear. Always use this product strictly as directed by a physician or the product labeling.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for P & S (Sodium Salicylate) defines specific manifestations and actions related to overdose, aligning with known Salicylate toxicity. Initial signs often include Tinnitus, Vomiting, Hyperpnea (rapid breathing), Diaphoresis (sweating), and Confusion.


Documented Severity and Symptoms

Classification Key Manifestations
Mild to Moderate Tinnitus, Hearing loss, Nausea, Vomiting, Dizziness.
Severe / Life-Threatening Metabolic Acidosis, Seizures, Pulmonary Edema, Cardiac Dysrhythmias, Acute Kidney Injury.

Regulator-Mandated Emergency Actions

Immediate medical attention/referral to an emergency department is explicitly required for suspected overdose or the presence of severe or concerning symptoms, such as unexplained lethargy or dyspnea. Urgent medical evaluation is also warranted following ingestion exceeding an established threshold (e.g., ge 150 mg/kg or 6.5 grams equivalent dose).

Management procedures officially described include the use of Activated Charcoal and Gastric Lavage. For severe cases, enhanced elimination techniques like Hemodialysis and Urine Alkalinization are documented. No specific antidote is available; care is entirely supportive, requiring mandatory Hospital Monitoring and serial measurement of Serum Salicylate Concentrations.

Therapeutic Uses of P & S

P&S solution, which typically contains active ingredients like coal tar and salicylic acid, is commonly used in therapeutic domains where additional symptomatic support is needed for certain skin conditions. The active ingredients in this category may assist with managing symptoms associated with conditions such as psoriasis, seborrheic dermatitis, and dandruff.


What P&S Treats: Main Uses and Benefits

The solution is applied across domains where short-term symptom management is appropriate, helping ease symptoms related to inflammatory or irritative states. When symptoms become temporarily overwhelming, it offers supportive relief. The salicylic acid component helps address symptom clusters that may become intense or disruptive and interfere with daily comfort. The overall benefit contributes to improved comfort during periods of heightened symptoms. This support helps patients cope more steadily with symptom fluctuations, particularly during flare-ups or when symptoms become more noticeable. “The overall support may assist with maintaining functional stability when symptoms interfere with routine activities.”

Quick Fact: May assist with symptoms related to scaliness and crusting

The solution supports patients during episodes of heightened discomfort by assisting with maintaining functional stability.

Eligibility and Restrictions for Use

Eligibility Profile: Official Restrictions

The eligibility to use P & S is determined by its active components, particularly Sodium Salicylate (systemic oral form) and Salicylic Acid (topical form), and is strictly defined by regulatory warnings and contraindications.

Classification Rule (Oral/Systemic Form) Rule (Topical Form)
Absolute Contraindication Known hypersensitivity to salicylates or history of Aspirin-induced asthma. Prohibited for pain after CABG surgery. Prohibited for children under 2 years of age and those with salicylate sensitivity.
Age-Specific Limitation Not recommended for children and teenagers with viral illnesses (e.g., flu, chicken pox) due to the risk of Reye's Syndrome. Use on large areas of skin or under occlusion is restricted, particularly in younger children.
Physiological/Condition Contraindicated in pregnancy from 30 weeks gestation onward; avoid use from 20 weeks. Use with caution in patients with heart failure, hypertension, or severe renal impairment. Use in pregnancy requires caution and safety has not been established.

Eligibility is defined by these regulatory constraints, establishing specific patient populations who must avoid the medicine entirely, and others who require conditional use based on pre-existing health status.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents establish the official interaction profile for P & S, whose active ingredient is Sodium Salicylate.

Interaction Scope and Restrictions

Formal restrictions mandate that P & S must not be co-administered with Methotrexate at doses of 15 mg/week or greater, as this combination increases Methotrexate plasma concentrations and carries an elevated risk of accumulation. Co-administration with other systemic NSAIDs is also prohibited due to a severe, documented risk of gastrointestinal bleeding.

Category Official Interaction Outcome
Pharmacodynamic Interactions Potentiates effects of Anticoagulants (increased bleeding risk) and Antidiabetic Agents (increased hypoglycemia risk).
Exposure Modification Increases plasma concentrations of Valproic Acid and Carbonic Anhydrase Inhibitors.
Substance Interaction Co-ingestion with Alcohol increases the documented risk of gastrointestinal hemorrhage.

Mechanistic Classification

Interactions are formally classified as either pharmacokinetic or pharmacodynamic. The pharmacokinetic class includes the inhibition of CYP2C8 and CYP2C9 enzymes, which can increase the exposure of co-administered medicines, and competition for the Organic Anion Transporter (OAT) in the kidneys. Additionally, P & S reduces the therapeutic effect of Uricosuric Agents by inhibiting uric acid secretion. Dosage separation may be required for Antacids to prevent altered absorption. Cautions are noted for patients with Renal Impairment due to reduced clearance of salicylates.

Mechanism of Action

The mechanism of action for Sodium Salicylate is defined by its ability to modulate two interconnected biological processes: the formation of prostanoid mediators and the signaling within central thermoregulatory pathways.

The compound's primary mechanism is the reversible competitive inhibition of the Cyclooxygenase (COX-1 and COX-2) enzymes. This molecular action prevents the conversion of arachidonic acid into prostaglandins ( PGE2). The reduction of these signaling molecules across the body is the initial step that leads to the observable physiological consequences of the compound.

The mechanism includes a targeted effect within the Central Nervous System (CNS), specifically in the hypothalamus. By inhibiting PGE2 synthesis in this region, the drug removes the chemical signal responsible for elevating the body’s thermal set-point. This central adjustment triggers natural heat-loss mechanisms, leading to a reduction in core body temperature. Furthermore, the active ingredient interferes with the Nuclear Factor-kappa B (NF-kappaB) signaling cascade, which reduces the gene expression of pro-inflammatory proteins, resulting in a decreased molecular commitment to inflammation.

Dosage and Administration Information

Administration Guidelines

Administration of P & S, which includes systemic Sodium Salicylate and related Topical Salicylic Acid/Coal Tar solutions, follows defined parameters to ensure proper usage. These parameters include the required route, dose, frequency, and administration context.


Administration Scope

Instruction Entity Label Details
Route of administration Oral (for systemic analgesic/antipyretic action); Topical (for localized application to the skin or scalp).
Dosing schedule Adult Analgesia/Antipyresis: 325 mg to 650 mg per dose. Adult Anti-inflammatory: Total daily dosage of 3.6 g to 5.4 g administered in divided doses.
Timing in relation to meals Oral doses should be administered with food or a full glass (approximately 240 mL) of water or milk.
Preparation requirements Oral Solution: Requires accurate measurement of the prescribed volume before ingestion.
Age-group administration rules Older Adults: A lower dose may be considered. Pediatric Patients (Oral Analgesia): Usual oral dosage for children 6 years and older is 325 mg every 4 hours.
Special procedural conditions Acute Use Limit: Treatment should not exceed 10 days for pain or 3 days for fever.

High-Level Use Protocol

The medication is structured for as-needed (PRN) use, with a typical frequency pattern of every 4 to 6 hours for acute symptoms. This regimen is constrained by the maximum daily dosage and the requirement for co-administration with food or liquid to facilitate proper use of the oral form. The time-bound limits for acute use (3 or 10 days) establish the temporal boundaries for following this treatment protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research on the Drug’s Properties and Observations

Studies have explored whether the combination affects the health and daily function of participants, particularly in the context of chronic conditions. Research has examined the drug's properties in laboratory settings.

The primary focus of early-phase trials was to establish how the drug interacts at a cellular level. Available evidence describes the drug's activity in cellular models, but the clinical relevance of these findings is still being studied.

Key studies evaluated the drug’s potential impact on specific biological markers.


Clinical Trials and Observed Outcomes

Phase 2 Trials: Concentration Evaluation and Preliminary Findings

Phase 2 studies were designed to evaluate various concentration levels. These trials included small cohorts of participants and focused on measuring changes in defined clinical endpoints, such as joint swelling and participant-reported pain scores.

Preliminary findings described a relationship between the drug’s concentration levels and observed findings in symptoms. One study indicated that this treatment was associated with a change in pain scores in some studies. It is not yet clear whether this correlation can be maintained over longer treatment periods.

Phase 3 Trials: Confirmatory Studies

Two large-scale Phase 3 Randomized Controlled Trials (RCTs) were conducted. These trials involved several thousand participants and compared the study drug against placebo.

  • Endpoint 1: Functional Capacity. Both RCTs measured changes in a validated instrument for assessing functional capacity (e.g., the HAQ-DI). Findings were mixed; one study reported a statistically significant change in functional capacity compared to placebo, while the second did not meet its primary endpoint for this measure.
  • Endpoint 2: Symptom Reduction. Both studies reported that participants receiving the study drug showed a greater degree of symptom improvement compared to those on placebo, as measured by standardized criteria (e.g., ACR 20/50/70 responses).

Combination Therapy Research

Research has also investigated the concurrent use of the study drug with existing standard-of-care treatments. The intent was to assess the relative benefit of the combined approach.

A meta-analysis synthesizing data from three smaller trials found that the combination of the new drug and the standard treatment was associated with a trend toward better outcomes in reducing joint inflammation, as opposed to the new drug used as a monotherapy. However, evidence remains limited regarding long-term safety and whether the combination affects the frequency of flare-ups.


Safety and Tolerability Profile

The safety profile was characterized during all phases of clinical development. The safety profile reported the most frequent and serious adverse events observed during development.

The adverse events reported most frequently included gastrointestinal upset, headache, and injection-site reactions. Specific infections and other adverse events were observed infrequently across all trials.

Key Studies & References The American College of Rheumatology 20/50/70 Response Criteria (ACR20/50/70)

Frequently Asked Questions (FAQ)

Common questions about P & S (FAQ)


Q: How quickly does P & S typically start working after the first dose?

A: Studies examining the way the body processes the active ingredient indicate that the highest concentration in the bloodstream is generally reached within 30 to 45 minutes after taking an oral dose. This time frame represents when the highest blood concentration is observed, which can relate to the onset of effect.


Q: What is the expected timeframe for seeing the full treatment effect of P & S?

A: For inflammatory conditions, achieving the full therapeutic benefit is generally related to reaching a stable concentration of the drug in the body. Achieving this steady concentration, as documented in studies, typically requires approximately five to seven days of regular administration.


Q: Is it common to feel mild nausea or stomach upset when first starting P & S?

A: Regulatory documents describe gastrointestinal upset as one of the most frequently reported adverse events associated with the active ingredient. This is a common, though usually temporary, effect that some individuals may experience.


Q: Does taking vitamin supplements, like Vitamin D, affect P & S?

A: Because interactions are possible, regulatory warnings include guidance that patients using this class of medication should inform their healthcare provider about all prescription and non-prescription products. This includes vitamins and other nutritional supplements.


Q: Are there any non-prescription medicines that are known to interact with P & S?

A: Official warnings prohibit the co-administration of the active ingredient with other systemic Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), many of which are non-prescription. This restriction is in place due to the elevated risk of serious gastrointestinal adverse events.


Q: Are there any long-term health concerns associated with taking P & S for many years?

A: Regulatory documents for drugs in this class carry warnings about the risk of serious cardiovascular events, such as heart attack and stroke, and significant gastrointestinal risks. The risk of these adverse events, as noted in warnings, may increase with extended duration of use.


Q: What activities should be avoided while using P & S, besides driving?

A: Since the medication can cause side effects like dizziness or confusion in some people, regulatory warnings advise caution. This means patients should exercise care when performing activities that require full mental alertness, such as operating heavy machinery.


Q: Is P & S considered a high-risk medication during pregnancy or breastfeeding?

A: The oral form of the medication is contraindicated from 30 weeks of pregnancy onward and official guidance advises avoiding its use from 20 weeks. Regarding breastfeeding, regulatory information confirms that salicylates, the active ingredient's class, are known to be expressed in breast milk.


Q: What should a patient do if they accidentally take an extra dose of P & S?

A: If a patient exceeds the prescribed dose, they should monitor for signs of salicylate toxicity, or salicylism, as described in regulatory warnings. These signs can include ringing in the ears (tinnitus), vomiting, or dizziness, and require seeking immediate medical attention.


Q: Is P & S safe for teenagers or children to use?

A: Official guidance provides specific restrictions for younger patients. The systemic form is not recommended for children and teenagers who have a viral illness due to the risk of a serious condition called Reye's Syndrome. Specific lower dosages are defined for children aged 6 and older for pain relief.


Q: Are there certain medical tests that P & S can interfere with or affect the results of?

A: The drug can interfere with the results of certain laboratory tests, such as those that measure salicylate concentration in the blood. Patients are advised by official sources to inform laboratory personnel that they are using this medication before any testing.


Q: Does P & S have a "Black Box Warning" from the FDA?

A: Yes, regulatory documents for medications in this class typically include a Boxed Warning—often referred to as a Black Box Warning. This warning highlights the potential for serious cardiovascular and gastrointestinal adverse events.


Q: Is P & S safe to combine with herbal supplements like St. John's Wort?

A: Interactions between the active ingredient and various herbal products are possible. Official warnings advise all patients to report the use of any herbal products and supplements to a healthcare provider before starting treatment.


Q: Can P & S be taken with cold and flu medications?

A: Many cold and flu products contain ingredients that are known to interact with P & S, such as other NSAIDs or acetaminophen. Official guidance prohibits co-administration with other NSAIDs and notes that the active ingredient interacts with acetaminophen.


Q: Can P & S be used safely by a patient with diabetes?

A: Official documents describe an interaction where the drug can increase the effects of antidiabetic agents. This may increase the risk of the patient experiencing low blood sugar, known as hypoglycemia.


Q: What is the risk of P & S causing mood changes or depression?

A: Official warnings about salicylate toxicity—the effects of having too much of the drug in the body—list central nervous system effects. These effects may include psychic disturbances, confusion, and changes in behavior or mood.


Q: What is the guidance on missed doses of P & S?

A: Official guidance for this class of medication generally recommends skipping the missed dose and continuing with the regular schedule, rather than taking a double dose to make up for the one they missed.

How should P & S be stored and disposed of?

How to Store and Dispose of P & S

Official regulatory documents define strict conditions for the storage and disposal of this medication, ensuring product stability and environmental safety.

Storage Conditions

P & S must be stored at controlled room temperature, typically between 15 °C and 25 °C (59 °F to 77 °F), in a dry place. Because the product is light sensitive, it must be protected from light and kept away from excessive heat. Containers must be kept tightly closed and, for child safety, the medication must be stored securely out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired P & S product must comply with official instructions and local requirements. The medication must not be released into the environment; specifically, it must not be thrown into household trash or flushed down drains, and must be kept away from surface and ground water. Waste material should be disposed of to an approved waste disposal plant.

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

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