Dolex Fem

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 12 years of age and over are instructed to take two (2) caplets every 6 hours as needed. The total daily dosage must not exceed 6 caplets within a 24-hour period.

The use of this medication is not recommended for children under 12 years of age.

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 known allergy to any of the ingredients in this product, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 6 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases when this product is taken concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Healthcare professionals should advise patients to limit the intake of other 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 heartbeat.

Before initiating treatment, patients should consult a healthcare provider if they have any of the following conditions: liver disease, glaucoma, respiratory issues such as emphysema or chronic bronchitis, or difficulty urinating due to prostate gland enlargement. Furthermore, it is advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers.

In the event of an accidental overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Patients are advised to discontinue use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days.

Side Effects

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

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

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any signs of a skin or general allergic reaction occur, patients are advised to discontinue use immediately and seek medical assistance.

Caffeine is also a component of this product, with the recommended dose containing approximately the same amount of caffeine as a cup of coffee. Patients should limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In clinical observations, excitability has been noted, particularly in children. Furthermore, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Therefore, patients are advised to avoid alcoholic beverages while taking this product and to exercise caution when driving or operating machinery.

Patients should stop use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days.

Drug Interactions

Co-administration of acetaminophen and warfarin may elevate the risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels.

Concurrent use of alcohol, sedatives, and tranquilizers with this product may enhance drowsiness. It is advisable to avoid the simultaneous use of these substances to mitigate the risk of excessive sedation and related adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is two caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an accidental overdose, it is essential to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 healthcare professional prior to using this medication. There is currently no available data on 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

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 that patients do not exceed the maximum daily dosage of 6 tablets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

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

Healthcare professionals are advised to remain vigilant, as the lack of immediate symptoms does not preclude the potential for serious health consequences. Early intervention can significantly impact the outcome of an overdose situation. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation following any suspected overdose incident.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, including skin reddening, blisters, and rash. Additionally, there is an alert regarding the potential for severe allergic reactions related to acetaminophen. In the event of a skin or general allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

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

Patients should be informed that excitability may occur, particularly in children, and they should be made aware of this potential side effect. Additionally, it is important to discuss the interaction of this product with alcohol, sedatives, and tranquilizers, as these substances may enhance drowsiness. Therefore, patients should be strongly advised to avoid alcoholic beverages while using this product.

Finally, healthcare providers should remind patients to exercise caution when driving a motor vehicle or operating machinery, as the use of this product may impair their ability to perform these activities safely.

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, within the range of 77-86°F (25-30°C). Proper storage conditions must be maintained 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 two caplets every six hours, with a maximum of six caplets in a 24-hour period. It is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)