Caffeine/Pyrilamine maleate/Acetaminophen

Description

No description information is available.

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 advised to take 2 softgels with water. This dosage may be repeated every 6 hours as needed. It is imperative not to exceed a total of 6 softgels within a 24-hour period.

For children under 12 years of age, it is recommended to consult a healthcare professional before administration. It is essential to adhere strictly to the recommended dosage to avoid potential adverse effects.

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 significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 softgels is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce 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 a skin or general allergic reaction, patients should discontinue use immediately and seek medical assistance.

Emergency Medical Help In cases of overdose, it is imperative to obtain emergency medical help 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 initially apparent.

Monitoring and Consultation Patients should be advised to stop taking the product and consult a healthcare provider if any of the following occur: the emergence of new symptoms, the presence of redness or swelling, worsening pain lasting more than 10 days, or a fever that worsens or persists for more than 3 days. Regular monitoring of 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 softgels 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 and seek medical assistance immediately.

Participants are instructed to stop use and consult a healthcare professional 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.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking the blood-thinning medication warfarin or are using sedatives or tranquilizers.

Drug Interactions

Acetaminophen has been shown to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently.

When acetaminophen is used in combination with alcohol, sedatives, or tranquilizers, there is a potential for increased drowsiness. Therefore, caution is advised when these substances are taken together with acetaminophen, caffeine, and pyrilamine maleate.

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 adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water, which may be repeated every 6 hours as needed, with a maximum of 6 softgels per day.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• The maximum recommended dosage is 6 softgels within a 24-hour period. Exceeding this limit may lead to severe liver damage.

• Patients should avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of liver injury.

• Consumption of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver damage.

Monitoring of liver function is advised for patients with pre-existing hepatic impairment or those who may be at increased risk for liver-related adverse effects. Regular assessment of liver enzymes may be warranted to ensure patient safety during treatment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include severe skin reactions such as hives, blisters, rash, skin reddening, and facial swelling. Additionally, allergic reactions have been noted, which may manifest as asthma (wheezing) and shock.

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 be encouraged to consult a doctor or pharmacist.

It is important to instruct patients to discontinue use and consult a doctor if they experience new symptoms, or if redness or swelling occurs. Additionally, patients should be advised to seek medical advice if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

Patients should be made aware that this product may cause drowsiness and should be cautioned against consuming alcoholic beverages while using it. Excitability may occur, particularly in children, and patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution should also be advised when driving a motor vehicle or operating machinery.

Patients should limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may 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 using 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 assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Caffeine and Pyrilamine Maleate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)