Paregoric

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Paregoric

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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 Paregoric

What is Paregoric?

Paregoric, also known as camphorated tincture of opium, is a liquid medication historically used primarily as an antidiarrheal agent. It is a hydroethanolic solution that contains a specific concentration of opium powder, which provides anhydrous morphine as its principal active constituent.

Composition and Classification

The formulation of paregoric consists of a blend of opium, anise oil, benzoic acid, and camphor, dissolved in a mixture of glycerin and ethanol. Due to the presence of morphine, paregoric is classified as a refined camphorated opium tincture. It is distinct from "Laudanum" (Deodorized Tincture of Opium), which contains a significantly higher concentration of morphine.

Mechanism of Action

Paregoric works by affecting the motility of the gastrointestinal tract. The morphine content acts on the smooth muscles of the intestines, leading to several physiological effects:

  • Decreased Propulsion: It slows the muscular contractions (peristalsis) that move contents through the digestive system.
  • Increased Muscle Tone: It increases the tone of the intestinal segments and the anal sphincter.
  • Fluid Absorption: By slowing the transit time of material through the gut, it allows for increased absorption of water and electrolytes, which results in firmer stools and a reduction in the frequency of bowel movements.

Historical Context

Paregoric has been used in various forms for centuries. While it was once a common household remedy for diverse ailments ranging from coughs to digestive distress, its use in modern medicine has become more specialized and limited. Today, it is recognized specifically for its properties in managing acute diarrhea when other first-line treatments are not suitable or effective.

Regulatory References

  1. NIH MedlinePlus Drug Information

What side effects are possible with Paregoric?

Possible Side Effects and Safety Information

The safety profile of Paregoric (Camphorated Tincture of Opium) is primarily defined by the properties of its active component, morphine. Official regulatory documentation does not provide numerical frequency classifications, but instead lists the adverse reactions observed in clinical use, categorized by the affected body system.


Documented Adverse Reactions

The most frequent adverse reactions documented in the official labeling generally fall into the following System-Organ Classes:

  • Nervous System Disorders: Includes lightheadedness, dizziness, sedation, euphoria, and dysphoria. These effects are noted to be more prominent in ambulatory patients.
  • Gastrointestinal Disorders: Includes common effects such as nausea, vomiting, and constipation.
  • Skin and Subcutaneous Tissue Disorders: Includes the occurrence of pruritus (itching).

Serious Safety Constraints and Risks

Official labeling defines significant safety constraints associated with the opioid component. The most serious risk is Respiratory Depression, which is a life-threatening decrease in respiratory function. Serious overdosage is further characterized by profound Central Nervous System Depression that can progress to stupor, coma, circulatory collapse, and death. The potential for developing physical dependence and drug abuse is officially documented, increasing with the duration of use.

Population-Specific Considerations

Specific caution is required when the medicine is used in older adults or debilitated patients, and those with severe hepatic or renal impairment. Furthermore, prolonged use during pregnancy is associated with the risk of Neonatal Opioid Withdrawal Syndrome.

Overdose and Emergency Response

A Paregoric overdose is primarily defined by the severe effects of its opioid component, Morphine, necessitating immediate emergency action. The officially documented clinical manifestations of an overdose largely involve profound depression of the central nervous system and respiratory function. Presentations may include extreme somnolence that progresses to stupor or coma, coupled with severe respiratory depression marked by a decrease in breathing rate, cyanosis, or Cheyne-Stokes respiration. Other physical signs include skeletal muscle flaccidity and cold, clammy skin.

The official labeling identifies severe overdosage as a life-threatening situation that can rapidly lead to apnea, circulatory collapse, cardiac arrest, and ultimately, death.

Due to these potential severe outcomes, regulatory documents mandate immediate action: in the event of accidental overdosage, individuals must seek professional assistance or contact a Poison Control Center immediately.

The documented emergency management procedures focus on reestablishing adequate respiratory exchange, which requires providing a patent airway and initiating assisted or controlled ventilation. The label specifies that the narcotic antagonist naloxone hydrochloride serves as a specific antidote against the resulting respiratory depression. Furthermore, the official prescribing information requires continued surveillance of the patient, as the duration of the opioid's effect may necessitate repeated doses of the antidote.

Therapeutic Uses of Paregoric

What Paregoric Treats: Main Uses and Benefits

Paregoric is applied across domains where additional symptomatic support is needed related to the digestive system. The key therapeutic benefits play a role in managing symptoms linked to acute discomfort. The medication is commonly used in the management of diarrhea symptoms, providing symptomatic relief that helps ease the overall burden of frequent, loose bowel movements.

The medication is generally used for the management of diarrhea. This supportive relief contributes to general functional stability during difficult episodes. In clinical scenarios, this medicine is applied in settings that involve acute or disruptive symptom patterns, especially when gastrointestinal symptoms create noticeable interference or heightened patient discomfort. This is relevant for easing clustered symptoms that accompany acute episodes of high bowel activity, such as intestinal cramping or the feeling of urgency.

“The primary focus is to help patients achieve a sense of stability and support comfort during symptomatic phases.”

Quick Fact: Helps with Frequent Bowel Movements

Regulatory References

  1. DailyMed Drug Labeling for Paregoric

Eligibility and Restrictions for Use

Who Can and Cannot Use Paregoric? (Eligibility Profile)

The official eligibility profile for Paregoric (Camphorated Tincture of Opium) strictly defines the populations who must not use the medicine and those who require significant caution, based on regulatory labeling.


Absolute Prohibitions (Contraindications)

Individuals are prohibited from using Paregoric if they have a known hypersensitivity to morphine or any component of the formulation. Use is also contraindicated in patients with diarrhea caused by poisoning until the toxic material has been fully eliminated.

Restricted or Conditional Use

Certain patient groups and conditions necessitate extreme caution or restricted use:

Population / Condition Regulatory Requirement
Severe Hepatic or Renal Impairment Use with caution due to altered drug clearance.
Pregnancy Conditional Use (Category C): Only if the benefit outweighs the potential fetal risk.
Lactation Caution is advised as morphine appears in breast milk.
Head Injury/Increased Intracranial Pressure Use with caution due to risk of exacerbated respiratory effects.
History of Substance Abuse Use with caution due to the inherent risk of misuse and dependence.

Age-Based Eligibility

  • Pediatric Patients: Use is often avoided (especially in neonates) due to high risk of adverse effects, including respiratory depression.
  • Geriatric Patients: Should be administered with caution, typically requiring reduced dosages.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Paregoric, a preparation containing Morphine, is defined primarily by pharmacodynamic reinforcement with substances that depress the central nervous system (CNS).

Documented Interaction Patterns

Co-administration with other CNS Depressants, including general anesthetics, tranquilizers, sedatives, hypnotics, and other narcotic analgesics, results in additive depressant effects. This combination is officially restricted due to the potential for profound sedation and respiratory compromise. The ingestion of alcohol is also classed as a CNS depressant interaction and carries the same restriction.

Contraindicated Combinations and Restrictions

The combination of Paregoric with olanzapine/samidorphan is formally contraindicated by regulatory agencies. This restriction is due to the risk of precipitating acute opioid withdrawal in individuals who are physically dependent on opioids. A time separation of at least 7 days is required before initiating olanzapine/samidorphan if the patient was taking Paregoric.

Other Significant Pharmacodynamic Risks

Concomitant use with Serotonergic Drugs, such as certain antidepressants, may result in the development of serotonin syndrome. Additionally, the combination with agents like phenothiazines or certain anesthetics can increase the risk of severe hypotension, particularly in individuals with compromised blood pressure maintenance.

Mechanism of Action

The mechanism of action for Paregoric is driven by the primary component, morphine, which exerts its effect on the peripheral nervous system within the gut wall. The mechanism begins at the cellular level with morphine functioning as an agonist at the mu-opioid receptor (MOR), which is abundant on neurons of the enteric nervous system (ENS).

Activation of the MOR initiates an inhibitory cellular cascade, coupling with the G i/ G o protein. This coupling suppresses the influx of calcium ions ( Ca^2+) and causes hyperpolarization of nerve cells, which directly reduces neuronal excitability. This reduced excitability leads to the presynaptic inhibition of key excitatory neurotransmitters, primarily acetylcholine, from being released by the motor neurons.

Disrupting acetylcholine signaling arrests the coordinated, propulsive muscle contractions known as peristalsis and simultaneously dampens neural signals that drive fluid and electrolyte secretion into the intestinal lumen. The physiological result of this dual suppression is a significant increase in the intestinal transit time and the maximization of available time for water and electrolyte reabsorption by the intestinal mucosa.

Dosage and Administration Information

How to Use Paregoric

Paregoric, formally known as Camphorated Tincture of Opium, is administered exclusively by the oral route as a liquid solution. Its use follows specific, standardized instructions regarding dose volume, frequency, and preparation as outlined in regulatory prescribing information.

Official Dosing and Frequency

The medication is supplied as an oral liquid containing 2 mg of anhydrous morphine per 5 mL volume. Usage is defined by distinct regimens for adults and pediatric patients:

  • Adults: The typical single dose is between 5 mL and 10 mL. This volume may be taken up to four times a day (or once every six hours), defining the maximum daily frequency.
  • Pediatric Patients: The dose is not standardized by volume but is based on the child’s body weight. The prescribed amount is calculated as 0.25 to 0.5 mL/kg of body weight, also administered up to four times daily.

Administration and Procedural Steps

To ensure accurate dosing of the liquid, a calibrated measuring device (such as an oral syringe or measuring spoon) must be used for every administration. The solution should be shaken well before the dose is measured. The liquid may be consumed with or without food and can be mixed with water for ease of swallowing.

For use over extended periods, official instructions specify that the dose must be gradually reduced upon discontinuation, rather than stopped abruptly, to follow a standardized tapering protocol.


Administration Scope (High-Level) Detail
Route of Administration Oral only (liquid tincture).
Adult Dose Range 5 to 10 mL per dose.
Maximum Frequency Up to four times a day
Pediatric Dosing Based on body weight (0.25 to 0.5 mL/kg).

Recent Clinical Evidence

Paregoric: Recent Clinical Evidence

Research on paregoric, historically known as a camphorated tincture of opium, is now largely confined to older trials and retrospective data, reflecting its shift toward limited or specialty clinical use. Due to the availability of newer agents, extensive contemporary studies on its efficacy and safety are not commonly performed.


Clinical Applications Investigated

The primary focus of past research and documented clinical use has centered on its antidiarrheal and analgesic properties. Studies have evaluated the influence of opium alkaloids, such as morphine and noscapine (found in paregoric), on gut motility.

  • Antidiarrheal Action: Early trials investigated how the drug was associated with reduced intestinal peristalsis, potentially leading to increased water absorption and stool consistency in patients with non-specific diarrhea. These studies generally compared paregoric to placebo or other common antidiarrheal agents of the time.
  • Pain Management: Retrospective analysis of hospital data has sometimes included paregoric as a mild analgesic, typically in settings where non-opioid pain relief was insufficient and stronger opioids were not warranted.

Safety Profile and Pharmacokinetic Data

Its safety profile, particularly the risk of dependence and withdrawal, is derived from long-term clinical experience and post-market surveillance. Research has characterized its metabolism, highlighting that morphine, the main active alkaloid, is processed in the liver. Due to the morphine content, studies have explored the correlation between paregoric use and common opioid side effects.

Research Area Findings Focus Current Status
Pediatric Use Neonatal opioid withdrawal syndrome (NOWS) treatment protocols. Specialized use in controlled hospital settings.
Adverse Effects Incidence of constipation, nausea, and sedation. Data primarily retrospective; prospective trials are rare.

Overall, evidence on paregoric is primarily historical, and its current use is governed by strict regulatory guidelines due to its opioid content.

Key Studies & References

  1. PAREGORIC liquid: Label information (DailyMed/NIH)
  2. Opium Tincture, USP (Deodorized) Prescribing Information (DailyMed/FDA) [Note: Paregoric is Camphorated Opium Tincture]
  3. The Pharmacological Basis of Therapeutics, 13th Edition: Opioid Agonists and Antagonists (General mechanism and effect on gut motility)
  4. Paregoric - Historical Perspective, Composition, and Clinical Use (Britannica)
  5. Pharmacokinetics (ADME) - StatPearls (General metabolism and distribution)

Frequently Asked Questions (FAQ)

Common questions about Paregoric (FAQ)

Q: How long do the effects of a dose of Paregoric typically last?

A: The official maximum frequency for taking Paregoric is up to four times a day, which is often interpreted in prescribing as a typical dosing interval. The terminal half-life of morphine, the active ingredient, is reported to be approximately two to four hours.

Q: What happens in the body when Paregoric slows down the gut?

A: The active component, morphine, works by decreasing the motility, or movement, of the intestinal wall. By diminishing digestive secretions and increasing muscle tone, the medication slows down the transit of contents. This increased transit time is intended to maximize water and electrolyte reabsorption, which helps improve stool consistency.

Q: How is the active ingredient in Paregoric measured?

A: Paregoric is provided as a liquid solution, and its strength is measured by the amount of active ingredient it contains. According to regulatory labeling, the liquid volume provides 2 milligrams (mg) of anhydrous morphine for every 5 milliliters (mL) of the solution.

Q: What are the risks of using Paregoric with certain anti-anxiety medications?

A: Anti-anxiety medications are generally classified as central nervous system (CNS) depressants. Co-administration with CNS depressants is restricted because it results in an additive depressant effect. This combination increases the risk of severe side effects such as profound sedation (extreme sleepiness) and serious breathing problems.

Q: Why do some sources say Paregoric is for pain relief?

A: Paregoric is officially classified as both an opioid antidiarrheal and an opioid analgesic (pain reliever). This dual classification exists because the active component in Paregoric is morphine, which is an established opioid used for managing pain.

Q: What is the risk of dependence with short-term use of Paregoric?

A: Physical dependence is a documented risk, and it generally increases with the duration of use. However, official information indicates that even taking therapeutic doses of the medication for a short period, such as one to two weeks, may result in mild withdrawal symptoms when the medicine is discontinued.

Q: Does Paregoric show up on standard drug tests?

A: Yes. Paregoric contains morphine, which is an opioid derived from opium. Standard drug screenings designed to detect opioids typically include morphine and its related compounds.

Q: Can taking Paregoric affect your driving ability?

A: Regulatory warnings state that Paregoric may impair the mental and physical abilities required for performing potentially hazardous tasks, such as driving a car or operating machinery. Caution should be exercised when engaging in such activities.

Q: What happens if you accidentally take two doses too close together?

A: Accidentally taking doses too close together significantly increases the risk of overdosage. Overdosage is characterized by profound central nervous system depression, progressing to severe breathing problems (respiratory depression), stupor, coma, circulatory collapse, and potentially death.

Q: Are there any dietary restrictions while taking Paregoric?

A: Paregoric can be consumed either with food or without it. However, because alcohol is a central nervous system depressant, the concurrent use of alcohol is strongly discouraged while taking this medication due to the potential for severe, additive depressant effects.

Q: Can Paregoric be taken with common OTC cold medicines?

A: Regulatory warnings advise caution, as many over-the-counter (OTC) cold medicines contain other central nervous system (CNS) depressants, such as antihistamines or alcohol. Combining these with Paregoric results in additive depressant effects, which can increase the risk of extreme sedation or breathing difficulty.

Q: What are the signs of a rare allergic reaction to Paregoric?

A: Paregoric should not be used by individuals with a known hypersensitivity (allergy) to morphine or any component of the formula. Documented adverse skin reactions include pruritus (itching). If severe or rare symptoms are experienced, prompt professional medical attention is appropriate.

Q: Is Paregoric a schedule III or schedule V controlled substance?

A: According to regulatory status under the Controlled Substances Act, Paregoric is officially classified as a Schedule III controlled substance.

Q: Does Paregoric lose its effectiveness over time?

A: Official information indicates that a patient may exhibit an increased tolerance to the effects of the narcotic component over time. When tolerance develops, higher doses are required to achieve the same effect, which can be associated with the development of dependence.

Q: Is the alcohol content in Paregoric high enough to matter?

A: Yes. Paregoric is an alcohol-based liquid, typically containing approximately 47% alcohol (ethanol) by volume. The co-administration of alcohol with this medicine is restricted due to the combined depressant effects on the central nervous system.

Q: Can Paregoric affect my sleep patterns?

A: As a central nervous system depressant, Paregoric is associated with side effects like sedation, euphoria, and dysphoria (unease). These effects on your nervous system and mood can potentially interfere with your regular or healthy sleep patterns.

Q: Can I take Paregoric if I have a history of liver problems?

A: Official guidelines recommend that patients with severe hepatic (liver) impairment should use Paregoric with caution. This is because the active ingredient, morphine, is metabolized in the liver, and impairment can alter the drug's clearance from the body.

Q: Is Paregoric effective for traveler's diarrhea?

A: Paregoric is officially indicated for the control of acute, nonspecific diarrhea. Regulatory labeling does not specifically distinguish between traveler's diarrhea and other forms of acute, nonspecific diarrhea.

Q: Can Paregoric cause a headache or dizziness?

A: Dizziness and lightheadedness are documented adverse effects of Paregoric that affect the nervous system. While headache is not explicitly listed, other gastrointestinal effects such as nausea and vomiting are reported. If severe or persistent gastrointestinal effects occur, consultation with a healthcare professional is appropriate.

Q: Why does Paregoric contain camphor?

A: Camphor is noted in labeling as a component of the camphorated formulation. The formulation is a traditional preparation, and the primary antidiarrheal action is opioid receptor-mediated by the morphine component.

Q: Is there a maximum number of days Paregoric should be used?

A: While a specific maximum number of days is not typically given, official guidance states that the medicine should be used for the shortest duration necessary to meet treatment goals. Prolonged use increases the risk of physical dependence, and withdrawal symptoms have been reported after short-term use.

Q: Can taking Paregoric interact with herbal supplements like St. John's Wort?

A: Due to the risk of serotonin syndrome (a potentially serious condition), caution is advised when combining Paregoric with serotonergic drugs, which may include certain herbal supplements. Regulatory information advises consulting a healthcare professional about all supplements before combining them with Paregoric.

Q: Does Paregoric impact the absorption of other oral medications?

A: The drug's mechanism of action involves significantly slowing the movement and transit time of contents through the gut. Because of this physiological change, Paregoric can potentially alter the rate and extent to which other orally administered medicines are absorbed by the body.

Q: Is Paregoric known to cause any mood changes or irritability?

A: Yes. Paregoric is known to cause changes in mood as part of its effects on the nervous system. Documented effects include both euphoria (a feeling of well-being) and dysphoria (a state of unease or dissatisfaction).

Q: How is Paregoric stored correctly to maintain its potency?

A: To maintain stability and potency, the product must be stored at a controlled room temperature (approximately 15 C to 30 C). The medication must be kept protected from light and stored in a tight, light-resistant container that is kept tightly closed.

Q: Does Paregoric have a known effect on blood pressure?

A: Paregoric may cause severe hypotension (low blood pressure), especially in patients with pre-existing issues maintaining blood pressure or when combined with certain other medications like phenothiazines. Caution is advised for individuals with these conditions.

Q: Is it normal to feel a mild stomach upset right after taking Paregoric?

A: Documented gastrointestinal adverse reactions include nausea and vomiting, and general upset stomach is reported as a side effect. If these or other gastrointestinal effects are severe or persistent, consultation with a healthcare professional is appropriate.

Q: Is Paregoric generally considered safe for children (high-level question)?

A: Due to a high risk of adverse effects, including respiratory depression (severe breathing issues), the use of Paregoric is generally avoided in pediatric patients, especially neonates. When administered, careful monitoring is required.

How should Paregoric be stored and disposed of?

How to Store and Dispose of Paregoric?

Paregoric, USP (Camphorated Tincture of Opium) must be stored and disposed of according to official regulatory labeling to ensure stability and safety.


Storage and Handling Requirements

The medicine requires storage at Controlled Room Temperature, defined as 15 C to 30 C (59 F to 86 F). Storage must avoid excessive heat and the product must be protected from light. The oral liquid must be kept in a tight, light-resistant container, kept tightly closed, and shaken well before using.

Child Safety and Disposal

Storage must be out of the sight and reach of children due to its opioid content. For disposal of unused or expired product, drug take-back programs are the preferred method. If take-back is unavailable, the official guidance permits flushing down the toilet to prevent accidental ingestion.

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

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