Caffeine/Pyrilamine maleate/Acetaminophen

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 gelcaps orally with water. This dosage may be repeated every 6 hours as needed, with a maximum limit of 6 gelcaps per day. For children under 12 years of age, it is essential to consult a doctor prior to administration. It is imperative that the recommended dose is not exceeded.

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 ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 6 gelcaps within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms indicative of such reactions can include hives, blisters, rash, skin reddening, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of overdose, it is imperative to obtain emergency medical help 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.

Patients should be advised to stop taking the product and consult a healthcare provider if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts longer than 3 days. Monitoring for these parameters is essential to ensure patient safety and effective management of any adverse effects.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 6 gelcaps within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include hives, blisters, rash, skin reddening, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Participants in clinical settings should stop use and consult a healthcare provider 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.

Patients with pre-existing conditions should consult a doctor prior to use if they have liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory issues such as emphysema or chronic bronchitis. Additionally, it is recommended that patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers consult a healthcare professional or pharmacist before using this product.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Caffeine and 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. For individuals aged 12 years and older, the recommended dosage is 2 gelcaps taken with water, which may be repeated every 6 hours as needed, with a maximum of 6 gelcaps per day.

Caution is advised as excitability may occur, particularly in children. It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 gelcaps within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to the recommended dosage and alcohol restrictions is essential to minimize the potential for adverse effects. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety during treatment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose.

Healthcare providers should monitor patients closely for any signs or symptoms that may arise from an overdose of the medication. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, it is recommended that healthcare professionals initiate supportive care immediately. This may involve maintaining the patient's airway, breathing, and circulation, as well as providing symptomatic treatment as necessary.

Additionally, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is advisable. It is crucial to gather as much information as possible regarding the substance involved, the amount taken, and the time of ingestion to facilitate appropriate treatment.

Documentation of the incident and any interventions performed should be meticulously recorded to ensure continuity of care and for future reference.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies. Additionally, there was no increase in fetal malformations observed in these studies. The available data do not indicate any concerns regarding teratogenicity or non-teratogenic effects in the context of animal testing.

Information regarding animal pharmacology and toxicology is not provided in the insert.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is necessary for both adults and children, even if no signs or symptoms are present.

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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use.

Patients should be instructed to stop using the product and consult a doctor if they experience new symptoms, or if they notice redness or swelling. They should also seek medical advice if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

It is important to inform patients that this product may cause drowsiness. They should be advised to avoid alcoholic beverages while using the product, as well as to be cautious when driving or operating machinery. Patients should also be made aware that excitability may occur, particularly in children, and that the use of alcohol, sedatives, or tranquilizers may enhance drowsiness.

Patients should limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Before using this product, patients should be encouraged to consult a doctor if they have liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing problems such as emphysema or chronic bronchitis. Furthermore, patients taking the blood-thinning medication warfarin, or those on sedatives or tranquilizers, should seek advice from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.