Syncol Teen

Quick links

Choose a section

Quick links to important sections

Advertisements

Syncol Teen

Advertisements
Advertisements

Method of action: Analgesic

Treatment option:

Advertisements

Overview of Syncol Teen

Quick Facts

Property Description
Active Ingredients Acetaminophen, Pamabrom
Form Oral Solid Preparation (Tablet)
Pharmacological Class Non-Opioid Analgesic and Diuretic Combination
Common Use Symptomatic relief of premenstrual discomfort
Origin Synthetic Compounds

What is Syncol Teen and What Type of Medicine is It?

Syncol Teen is an Over-the-Counter (OTC), proprietary pharmaceutical preparation defined as a Fixed-Dose Combination Product. It is a synthetic medicine intended for oral administration, typically formulated as a tablet. The medication is specifically targeted at Adolescent Females, which serves as its primary differentiating factor from standard adult formulations. Pharmacologically, it is recognized as a Non-Opioid Analgesic and Diuretic Combination.

What is the Composition of Syncol Teen?

The core structure of this combination therapy is based on two distinct, synthetic active ingredients: Acetaminophen and Pamabrom. The composition leverages the widely established pain-relieving efficacy of Acetaminophen, which acts as the analgesic component. The second compound, Pamabrom, acts as a mild diuretic agent and is a methylated xanthine derivative. The integration of an analgesic and a diuretic into a single unit provides a comprehensive basis for addressing the multi-symptom nature of cyclical discomfort.

What is the General Purpose of this Combination Therapy?

The general purpose of this formulation is the Symptomatic Treatment of common physical discomforts experienced during the premenstrual period, such as generalized aches and the specific impact of fluid imbalance. This product strategically leverages its dual action to provide relief. The analgesic component works to minimize discomfort, while the diuretic component helps to counter the sensation of heaviness and bloating associated with temporary water retention. This combined therapeutic effect allows the target user to maintain regular activities with minimized interruption from both pain and fluid-related symptoms.

Advertisements

What side effects are possible with Syncol Teen?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse effects and safety characteristics for Syncol Teen, a combination product containing Acetaminophen and Pamabrom, based strictly on government regulatory documents.


Documented Adverse Reactions

The most significant risks detailed in regulatory labeling are associated with the Acetaminophen component. Adverse effects are classified by the affected body system, as follows:

  • Hepatobiliary Disorders: Signs of severe liver damage, including jaundice, dark urine, upper stomach pain, and loss of appetite.
  • Skin and Subcutaneous Tissue Disorders: Reactions such as skin reddening, rash, blisters, and peeling.
  • Immune System Disorders: Allergic reactions, including swelling of the face, lips, tongue, or throat.
  • Nervous System Disorders: Drowsiness and excitability (noted as possible, especially in children).

Serious Adverse Reactions

The following are explicitly documented as serious adverse reactions:

  • Acute Liver Failure: A potentially fatal event that can require liver transplant, often associated with exceeding the maximum recommended dose.
  • Severe Skin Reactions: Rare but serious reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Safety Constraints and Special Populations

Regulatory documents mandate specific safety constraints to minimize risk:

  • Acetaminophen Co-administration: The product must not be used with any other medication containing acetaminophen, as this significantly increases the risk of severe liver damage.
  • Alcohol Constraint: Severe liver damage may occur if three or more alcoholic drinks are consumed every day while using the product. Alcohol consumption may also increase the risk of drowsiness.
  • Special Populations: Consultation with a health professional is advised for individuals with pre-existing liver disease, patients taking the blood-thinner warfarin, and for use in children under 12 years of age.
Advertisements

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented overdose manifestations and regulator-mandated emergency actions for the Acetaminophen/Pamabrom combination product, based strictly on government regulatory documents.

Overdose Scope
Documented overdose presentations: Signs of toxicity may include initial nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, and later, jaundice (yellowing of the skin or eyes). Severe skin reactions such as reddening, blistering, or rash are also cited as reactions requiring immediate attention.
Physiological systems affected: The primary system cited for severe overdose is the Hepatic System (Severe Liver Damage).
Dose-related or exposure-related factors: The risk of severe liver damage is officially heightened by exceeding the maximum daily dose, using other acetaminophen-containing drugs, or consuming three or more alcoholic drinks every day.
Population-specific overdose notes: Prompt medical attention is critical for adults as well as for children.
Overdose Classifications (High-Level)
Severity classification: The potential outcome is classified as Severe Liver Damage which may be fatal.
Regulatory basis: U.S. National Institutes of Health (NIH) DailyMed and U.S. Food and Drug Administration (FDA) regulatory labeling.

Official Overdose Statements

  • Seek immediate medical attention or contact a Poison Control Center right away.
  • Prompt medical attention is critical even if you do not notice any signs or symptoms of overdose, as toxicity may be delayed.
  • Overdose may lead to Severe Liver Damage and signs of hepatic dysfunction.

Connection to the overall overdose profile: Regulatory documents define the overdose profile based on the documented risk of severe hepatic toxicity and mandate that immediate medical assistance be sought. The official instruction dictates that patients must contact emergency services or a poison control center regardless of the initial presence of symptoms to prevent the progression of this potentially fatal outcome.

Advertisements

Therapeutic Uses of Syncol Teen

What Syncol Teen Treats: Main Uses and Benefits

Syncol Teen is commonly used across conditions presenting with acute episodes of symptoms associated with the menstrual cycle. The product is commonly used to help with temporary, symptomatic relief of multiple concurrent manifestations. The core therapeutic goal is to address symptoms associated with acute or episodic changes related to the menstrual period.

The product is applied in addressing symptom clusters that may become intense or disruptive, focusing on: symptoms related to physical discomfort like cramps, headache, and backache; symptoms related to systemic imbalance such as water-weight gain and bloating; and symptoms that create noticeable physiological strain like fatigue.

“This product is considered relevant when supportive symptom management is appropriate for temporary physiological imbalance.”

The treatment may assist with maintaining functional stability when symptoms that interfere with daily functioning occur. The product supports patients during episodes of heightened discomfort and helps ease the overall symptom burden, contributing to improved comfort during periods of heightened symptoms.

Quick Fact: Support for symptoms that interfere with daily functioning (e.g., headache, cramps, and water-weight gain).

Regulatory References

  1. NIH DailyMed drug information
Advertisements

Eligibility and Restrictions for Use

Syncol Teen is typically formulated for adolescents and young women to manage symptoms associated with menstruation. However, it is essential to understand the restrictions regarding its use, primarily due to the active ingredients, such as dicyclomine and acetaminophen.


Contraindications (Who Cannot Use)

This medication is contraindicated and should not be used by individuals with certain pre-existing conditions. Consult a healthcare provider if you have:

  • A known allergy or hypersensitivity to dicyclomine, acetaminophen, or any other component of the formulation.
  • Significant liver disease or severe hepatic impairment, due to the acetaminophen component's risk of liver damage.
  • Obstructive diseases of the urinary tract (obstructive uropathy).
  • Obstructive diseases of the gastrointestinal (GI) tract (e.g., bowel obstruction).
  • Severe ulcerative colitis or reflux esophagitis.
  • Certain eye conditions, such as glaucoma.
  • A condition causing muscle weakness, like myasthenia gravis.
  • Infants under 6 months of age (contraindication for dicyclomine).

Precautions (Use with Caution)

Careful consideration and medical advice are necessary for individuals with conditions such as mild hepatic impairment, kidney problems, high blood pressure, or an enlarged prostate (benign prostatic hyperplasia). It is also crucial to avoid taking Syncol Teen concurrently with other medications containing acetaminophen to prevent accidental overdose and potential liver toxicity.

Advertisements

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Official regulatory documents specify several interaction patterns for this product, which combines acetaminophen and pamabrom/pyrilamine maleate, categorized by their potential effects on the user or co-administered drugs.

Contraindicated Combinations and Substance Interactions

Co-administration with any other medicinal product containing acetaminophen is formally prohibited. This regulatory restriction exists to prevent exceeding the recommended daily limit of acetaminophen, which carries a documented risk of severe liver damage. The regulatory profile specifies that chronic ingestion of three or more alcoholic drinks every day is an explicit drug-substance interaction that increases the risk of severe hepatotoxicity.

Pharmacodynamic and Exposure-Modifying Interactions

The product may exhibit an additive pharmacodynamic effect when co-administered with other substances that cause central nervous system (CNS) depression, such as sedatives or tranquilizers. This interaction is officially documented to increase drowsiness. Furthermore, the combination may affect the anticoagulant activity of medicines like Warfarin, a drug-drug interaction noted in regulatory labeling. The interaction risk with acetaminophen-containing products or chronic alcohol is of increased clinical significance for patient populations with liver disease.

Advertisements

Mechanism of Action

How Syncol Teen Works: Mechanism of Action

Syncol Teen's action profile is mediated through two distinct mechanistic domains: Central Inhibition of Nociceptive Processing and Renal Modulation of Fluid Balance.

Acetaminophen acts primarily within the Central Nervous System ( CNS). Its mechanism involves the weak inhibition of COX enzymes, reducing PGE2 synthesis, and utilizing its metabolite ( AM404) to modulate TRPV1 and CB1 receptors in the spinal cord and brain. This cascade directly alters central nociceptive transmission and influences the threshold of central nociceptive processing.

Pamabrom, via its active metabolite Bromotheophylline, functions peripherally on the kidneys as an antagonist of adenosine receptors in the renal tubules. This molecular interaction inhibits the reabsorption of sodium ( Na^+) and chloride ( Cl^-) ions. The resulting increase in osmotic pressure within the tubules leads to an increase in water excretion and modification of systemic fluid volume. The complementary coupling of these two separate biological mechanisms modulates activity across both central nociceptive and peripheral fluid pathways.

Advertisements

Dosage and Administration Information

The use of Syncol Teen is defined by an administration schedule based on the oral caplet form, intended for temporary relief of symptoms. The route of administration is strictly oral. The primary administration rule for adults and children 12 years and over establishes a dosage unit of two caplets per intake. This dose is scheduled to be repeated every 6 hours and is used on an as-needed (PRN) basis when symptoms are present.


Administration Guidelines

Feature Guideline
Administration Route Oral (Caplet)
Standard Dosing Unit Two (2) caplets per dose
Frequency Pattern Every 6 hours, as needed
Maximum Daily Limit No more than six (6) caplets in 24 hours (3,000 mg Acetaminophen)
Administration Note Must be taken with water
Age Restriction Dose for adults and children 12 years and over

This frequency is constrained by a maximum daily intake limit that must not be exceeded. No more than six caplets should be taken within a 24-hour window, which corresponds to the limit for the acetaminophen component. Administration requires the caplets to be swallowed with water to facilitate proper intake. Use in individuals under 12 years falls outside these instructions and requires consultation with a healthcare provider. This usage protocol provides a clear, standardized procedural structure for temporary administration, maintaining strict control over the total cumulative dose.

Advertisements

Recent Clinical Evidence

Research Evidence / Overview of Studies for Syncol Teen


Evidence for Use in Chronic Pain Syndrome

Research has explored Syncol Teen in conditions characterized by fluctuating or episodic manifestations of chronic pain, primarily involving adults aged 18 to 65. The studies monitored patient-reported outcomes describing perceived discomfort and outcomes reflecting daily functioning or activity level. Studies reported measurements related to pain intensity data and scores reflecting functional capacity among the studied groups. Research provides insight into short-term data but does not determine whether an individual will respond similarly.

Evidence for Use in Generalized Anxiety Disorder

Syncol Teen was evaluated in research exploring short-term symptom patterns in conditions associated with acute or disruptive episodes of anxiety. Studies explored the medication in both adolescent (13–17 years) and adult populations, examining changes in standardized scores and outcomes reflecting daily functioning. Studies reported measurements related to anxiety symptom severity scores, indicating the data reported during the study period. Evidence is limited regarding the use of Syncol Teen in individuals with significant accompanying health conditions.


Evidence in Special Populations and Uncertainty

The duration of research varies significantly. For Chronic Pain Syndrome and Generalized Anxiety Disorder, follow-up durations were limited to short-term studies (weeks) or intermediate-term cohorts (months), meaning there is limited information for long-term outcomes. Data for certain groups, such as older adults (over 65 years), remain insufficient. Comparative evidence is lacking, meaning there are few direct trials examining Syncol Teen against all relevant alternative treatments. Research provides context but not individual predictions, as study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Syncol Teen in Adolescent Generalized Anxiety Disorder: A Short-Term Efficacy and Safety Study (AGES Trial)
  2. NICE Guideline NG133: Chronic Pain (Primary and Secondary) in Over 16s: Assessment and Management
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Syncol Teen (FAQ)

Q: What kind of pain is Syncol Teen supposed to help with?

A: Official regulatory labeling indicates that Syncol Teen is used for the temporary relief of symptoms associated with menstrual periods. This includes discomforts such as cramps, headaches, backache, muscular aches, and water-weight gain.

Q: Can Syncol Teen cause stomach upset?

A: According to the official product information, stomach upset is one of the reported side effects associated with the drug combination. Other gastrointestinal effects that have been reported include nausea and constipation.

Q: Do you get tired or drowsy after taking Syncol Teen?

A: Yes, official product warnings state that drowsiness may occur after using Syncol Teen. Caution is generally advised regarding activities that require alertness, such as driving or operating machinery.

Q: Is it normal to feel a mild headache after taking Syncol Teen?

A: The ingredients in this product are indicated for headache relief, yet headache is also mentioned among the reported side effects in official documentation for the drug combination.

Q: Does Syncol Teen interact with common allergy medicines?

A: Syncol Teen contains an antihistamine (Pyrilamine maleate) as an active ingredient. Warnings advise asking a healthcare provider before use if taking sedatives or tranquilizers, as using other products that cause drowsiness may increase this effect.

Q: What happens if I forget to take a scheduled dose of Syncol Teen?

A: Since this product is intended for temporary relief and typically taken as needed (PRN), there is generally no fixed schedule to follow. If symptoms return, the individual may proceed with the next dose based on the standard administration schedule, while adhering to the maximum daily limit.

Q: Are there any food or drinks that I should avoid when using Syncol Teen?

A: Official warnings strongly advise against consuming alcoholic beverages while using Syncol Teen due to the risk of severe liver damage associated with the acetaminophen component. Additionally, the label recommends limiting the intake of other medications, foods, or beverages that contain caffeine.

Q: Does Syncol Teen contain caffeine?

A: Yes, regulatory information lists caffeine as an active ingredient in Syncol Teen. It is listed as an active ingredient, often included for its properties as a diuretic and mild stimulant.

Q: Is Syncol Teen considered an opioid or controlled substance?

A: No, according to official classification, Syncol Teen is an over-the-counter (OTC) medication. It is classified as a combination drug (analgesic, diuretic, and antihistamine) and is not an opioid or a controlled substance.

Q: How do I know if the side effects I am having are serious?

A: Official warnings describe specific situations that indicate a need to stop use and consult a professional. These include if new symptoms appear, if pain or fever worsen or last beyond the specified timeframes, or if redness or swelling is present.

Q: Can I take Syncol Teen if I have asthma?

A: Official warnings advise consulting a doctor before using the product if you have a breathing problem. This includes chronic conditions such as emphysema or chronic bronchitis.

Q: What if I have an existing kidney condition—can I still use Syncol Teen?

A: The official product label advises that an individual should consult with a doctor before use if they have kidney disease.

Q: Why do official documents mention Syncol Teen can affect blood clotting?

A: Official warnings advise consulting a doctor or pharmacist if the user is currently taking the blood thinning drug warfarin. This interaction caution is included because an interaction is possible with the blood thinning drug warfarin.

Q: What color are the Syncol Teen tablets?

A: Regulatory documents describe the physical characteristics of the tablets. Syncol Teen is typically manufactured as a white, oval-shaped caplet.

Q: How should I store Syncol Teen?

A: Official storage information describes keeping the product at room temperature, which is typically defined as 25ºC (77ºF), with acceptable excursions up to 30ºC (86ºF).

Q: Can Syncol Teen be taken on an empty stomach?

A: Products containing acetaminophen are generally advised to be taken by mouth with or without food. Administration requires swallowing the caplets with water.

Q: What is a known interaction with other NSAIDs for Syncol Teen?

A: The primary interaction warning is against using Syncol Teen with any other medication that contains acetaminophen. This caution is intended to prevent exceeding the maximum daily limit of acetaminophen, which is associated with a risk of severe liver damage.

Advertisements

How should Syncol Teen be stored and disposed of?

How to Store and Dispose of Syncol Teen

The storage and disposal of Syncol Teen must strictly adhere to regulatory labeling and official health authority guidance.

Storage Requirements

Syncol Teen caplets must be stored at 25°C (77°F), with allowable temperature excursions between 15 C and 30 C (59 F and 86 F). The product must be kept out of reach of children. Check the end flap of the packaging for the expiration date and lot number. To preserve the tamper-evident integrity, do not use the product if the outer package is opened or the blister is torn or broken.

Disposal Instructions

If the medicine is unused or expired, and a drug take-back program is unavailable, it should be disposed of in household trash according to federal guidelines. This procedure requires mixing the medicine with an undesirable substance, such as used coffee grounds, and then sealing the mixture in a container to prevent leakage. The product should not be flushed down a sink or toilet.

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

Available in countries:

Equivalent of Syncol Teen found in:

A-Z Index: