Basic Care Severe Cold and Flu

Description

This formulation contains Acetaminophen, a pain reliever and fever reducer, Dextromethorphan HBr, a cough suppressant, and Phenylephrine HCl, a nasal decongestant. The product is available in a convenient packet form, with each pack containing a blend of green tea and honey lemon flavors. The product is supplied in a total of six packets.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold. Specifically, it alleviates minor aches and pains, minor sore throat pain, headache, nasal and sinus congestion, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

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 one packet every four hours as needed, while symptoms persist. It is important not to exceed six packets within a 24-hour period unless directed by a healthcare professional. For children under 12 years of age, the use of this product is not recommended.

To prepare the dosage, the contents of one packet should be dissolved in 8 ounces of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If utilizing a microwave for preparation, the contents of one packet should be added to 8 ounces of cool water. The mixture must be stirred briskly before and after heating to ensure proper dissolution. Care should be taken not to overheat the solution.

Healthcare professionals should remind patients to adhere strictly to the recommended dosage and to consult a physician if symptoms persist or worsen.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 12 years of age.

• In individuals with a history of allergic reactions to this product or any of its ingredients.

• Concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. If uncertain about the presence of acetaminophen in a medication, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. For clarification regarding MAOI content in prescription drugs, consult a healthcare professional.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

Healthcare professionals should recommend that patients consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a chronic cough associated with smoking, asthma, or emphysema. Additionally, patients on a sodium-restricted diet should seek medical advice before use. It is also important to advise patients taking the anticoagulant warfarin to consult with a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts longer than three days; if redness or swelling occurs; if new symptoms develop; or if pain, cough, or nasal congestion worsens or persists beyond seven days. A return of cough accompanied by rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions include severe liver damage, which may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients experiencing a sore throat should consult a doctor if the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if pain, cough, or nasal congestion worsens or persists for more than seven days. Furthermore, if a cough recurs or is accompanied by a rash or headache that lasts, this may indicate a serious condition requiring prompt medical evaluation.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication, due to the potential for increased bleeding risk.

Co-administration with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients are advised to verify the presence of acetaminophen in any other medications they may be taking by consulting a healthcare professional.

This product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it is contraindicated for a period of two weeks following the discontinuation of an MAOI. Patients uncertain about the presence of an MAOI in their current medications should seek guidance from a healthcare professional before using this product.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is one packet.

In the event of an overdose, it is crucial to seek prompt medical attention for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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

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 absence of guidance necessitates careful clinical judgment.

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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, the consumption of three or more alcoholic beverages daily while using acetaminophen can exacerbate the risk of severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider the need for liver function tests and other relevant evaluations. Prompt intervention is crucial to mitigate potential liver injury and ensure appropriate management of the overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin 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 at 1-800-222-1222 in the event of an overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be encouraged to consult a healthcare professional before using the medication if they are pregnant or breastfeeding. It is important to stress the necessity of adhering to the recommended dosage and not exceeding it.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the medication and seek medical advice if their fever worsens or persists for more than three days.

Patients should also be informed to stop use and contact a healthcare provider if they notice any redness or swelling, or if new symptoms arise. Furthermore, they should be cautioned to seek medical attention if pain, cough, or nasal congestion worsens or lasts longer than seven days. It is crucial to inform patients that they should return to their healthcare provider if a cough recurs or occurs alongside a rash or headache that persists, as these may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one packet every four hours while symptoms persist, not exceeding six packets in a 24-hour period unless directed by a healthcare professional. The contents of each packet should be dissolved in 8 oz. of hot water and sipped while hot, with the entire drink consumed within 10-15 minutes. If using a microwave, the packet's contents should be added to 8 oz. of cool water, stirred briskly before and after heating, and care should be taken to avoid overheating.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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