Syncol Max

Description

SYNCOL MAX® is a pharmaceutical product containing a combination of active ingredients: Acetaminophen, Caffeine, and Pyrilamine Maleate. It is indicated for the relief of menstrual cramps and provides additional benefits for symptoms associated with fatigue, bloating, headache, and backache. The product is presented in a dosage form of 12 caplets.

Manufactured by Laboratorios Sanfer S.A. de C.V., located at Blvd. Adolfo López Mateos No. 314, Col. Tlacopac, CDMX, 01049, Mexico, SYNCOL MAX® is produced in compliance with all United States regulatory and quality requirements for pharmaceutical products.

A tamper evident warning is included, stating: "DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING."

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including bloating, headache, water-weight gain, cramps, backache, fatigue, and muscle aches.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets with water. This dosage may be repeated every 6 hours as needed. It is imperative that patients do not exceed a total of 6 caplets in a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In individuals with a history of allergic reactions to this product or any of its components, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that liver damage may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

General precautions should be taken when considering this product for patients with specific health conditions. Healthcare professionals should recommend that patients consult a doctor prior to use if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop taking the product and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use this product in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients are advised to stop use immediately and seek medical assistance.

Patients should not use this product if they have a history of allergic reactions to acetaminophen or any of its ingredients, or if they are currently taking any other medications that contain acetaminophen, whether prescription or nonprescription. It is recommended that patients consult a doctor before use if they have difficulty urinating due to prostate enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, patients taking blood thinners like warfarin or sedatives should also seek advice from a healthcare professional prior to use.

While using this product, patients may experience drowsiness, and it is advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Excitability may occur, particularly in children, and caution is recommended when driving or operating machinery. Patients should limit the intake of caffeine-containing products, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate.

Patients are instructed to stop use and consult a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking any of the following medications or substances:

Anticoagulants

• Warfarin: The concomitant use of this product with warfarin may necessitate careful monitoring due to potential alterations in anticoagulant effects.

CNS Depressants

• Sedatives and Tranquilizers: Co-administration with sedatives or tranquilizers may enhance drowsiness. Patients should be advised to exercise caution and consider dosage adjustments as necessary.

Alcohol

• The use of alcohol in conjunction with this product may further increase drowsiness. Patients are advised to limit alcohol consumption while using this product.

Caffeine

• It is recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. Monitoring of caffeine intake is advised to avoid these potential effects.

Packaging & NDC

Below are the non-prescription pack sizes of Syncol Max (acetaminophen, caffeine, pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients must not exceed 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safety and appropriateness of treatment. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use due to potential teratogenic effects.

Non-teratogenic effects associated with the use of this product may include drowsiness and excitability, particularly in children. It is recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is essential to instruct patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Patients should be advised to discontinue use and consult a doctor if they experience new symptoms, or if they notice redness or swelling. Additionally, they should be informed to stop use and seek medical advice if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

Patients should be made aware that drowsiness may occur while using this product, and they should avoid alcoholic beverages during its use. It is important to inform them that the combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness. Furthermore, patients should be cautioned that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery.

Healthcare providers should recommend that patients limit the intake of caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should be encouraged to consult a doctor before using this product if they have difficulty urinating due to an enlarged prostate gland, liver disease, glaucoma, or any breathing problems such as emphysema or chronic bronchitis. Additionally, they should be advised to seek guidance from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken. The expiration date and lot number can be found on the end flap of the packaging.

For optimal storage, the product should be maintained at a temperature of 25ºC (77ºF). Temporary excursions are permissible within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 6 hours as needed, with a maximum of 6 caplets per day. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients on potential drowsiness associated with the medication, advising them to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Patients should also be informed that excitability may occur, particularly in children, and caution is advised when driving or operating machinery. Additionally, it is recommended to limit the intake of caffeine-containing products while using this medication. Pregnant or breastfeeding patients should seek guidance from a healthcare professional before use.

Drug Information (PDF)

This file contains official product information for Syncol Max, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)