Contac Cold and Flu

Description

NDC 71179-003-08, CONTAC® COLD & FLU is a multi-symptom formulation that combines Acetaminophen, Doxylamine Succinate, and Dextromethorphan HBr. This product serves as a pain reliever and fever reducer, an antihistamine, and a cough suppressant. It is presented in the form of 8 liquid gels, which are liquid-filled capsules designed for effective delivery of the active ingredients.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 liquid gels taken with water every 6 hours, not to exceed 8 liquid gels in a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this medication is not recommended for children under 4 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

• Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to the guidelines.

Liver Warning Severe liver damage may occur if the following conditions are met: exceeding 8 liquid gels within a 24-hour period, using this product in conjunction with other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at increased risk due to concurrent medication use or alcohol consumption.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Discontinuation Criteria Patients should stop use and consult a doctor if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or lasts longer than 3 days; redness or swelling is observed; new symptoms develop; or if cough recurs or is accompanied by a rash or headache that persists.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 the maximum daily dosage of 8 liquid gels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, 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 reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a doctor promptly.

Furthermore, patients should stop use and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts more than 7 days; fever worsens or lasts more than 3 days; redness or swelling is present; new symptoms develop; or if a cough returns or occurs with a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, and for a period of two weeks following the discontinuation of an MAOI.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these may enhance the sedative effects and increase the risk of drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

It is important to note that the combined use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Contac Cold and Flu (acetaminophen, dextromethorphan hydrobromide and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The medication is not recommended for children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed the maximum daily amount of 8 liquid gels within a 24-hour period. Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Furthermore, patients with compromised liver function should be advised that the risk of severe liver damage increases significantly with the consumption of 3 or more alcoholic drinks daily while using this product. It is recommended that healthcare providers assess liver function and consider these factors when prescribing this medication to patients with hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Maximum Daily Dosage Taking more than 8 liquid gels within a 24-hour period can lead to severe liver damage. It is crucial for healthcare professionals to advise patients to adhere strictly to the maximum daily dosage to mitigate the risk of toxicity.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also result in severe liver damage. Healthcare providers should evaluate a patient's medication regimen to prevent potential interactions that could exacerbate the risk of overdose.

Alcohol Consumption Patients who consume 3 or more alcoholic drinks daily while using this product are at an increased risk of severe liver damage. It is essential for healthcare professionals to counsel patients on the dangers of alcohol consumption during treatment with this product.

In the event of suspected overdosage, immediate medical attention is recommended. Monitoring liver function and providing supportive care are critical components of management.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be instructed not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is important to counsel patients to avoid consuming alcoholic beverages while taking this medication, as alcohol can exacerbate drowsiness.

Additionally, patients should be cautioned about the potential effects on their ability to drive or operate machinery safely. They should be informed that the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may further increase drowsiness, and they should exercise caution in these situations.

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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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