Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including fever, headache, sore throat, minor aches and pains, cough due to minor throat and bronchial irritation, nasal congestion (for daytime use only), and runny nose and sneezing (for nighttime use only).

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the maximum daily limit. The maximum allowable dosage is 8 capsules within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 capsules taken with water every 4 hours as needed.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction 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.

The product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare provider if their prescription includes an MAOI.

This product should not be administered to individuals with a known allergy to it or any of its ingredients, as this may lead to serious allergic reactions.

Additionally, the product is not intended for use in children to induce sleep.

Exceeding the recommended dosage is contraindicated, and the consumption of alcoholic beverages should be avoided while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have any of the following conditions: cough with excessive phlegm, liver disease, difficulty urinating due to prostate enlargement, heart disease (daytime use only), diabetes (daytime use only), thyroid disease (daytime use only), high blood pressure (daytime use only), persistent or chronic cough associated with smoking, asthma, or emphysema (daytime use only), breathing problems or chronic cough lasting through the night (nighttime use only), or glaucoma (nighttime use only).

In cases of accidental overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center at 1-800-222-1222, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness (daytime use only), if pain, nasal congestion, or cough worsens or persists beyond seven days (daytime use only), if pain or cough worsens or lasts more than seven days (nighttime use only), if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

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 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, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

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

Common adverse reactions may include nervousness, dizziness, or sleeplessness, particularly during daytime use. Patients should also be cautious if pain, nasal congestion, or cough worsens or lasts more than seven days during daytime use, or if pain or cough persists for more than seven days during nighttime use. Fever that worsens or lasts more than three days, as well as the presence of redness or swelling, should prompt a consultation with a healthcare provider. New symptoms or a cough that returns or occurs with a rash or headache that lasts may indicate a serious condition, warranting medical attention.

When using this product, patients may experience excitability, particularly in children, and marked drowsiness during nighttime use. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients are advised to exercise caution when driving or operating machinery during this time.

Patients should seek medical advice before using this product if they have a cough associated with excessive phlegm, liver disease, difficulty urinating due to prostate enlargement, heart disease, diabetes, thyroid disease, high blood pressure, or a persistent or chronic cough related to smoking, asthma, or emphysema. For nighttime use, patients with breathing problems or chronic coughs, as well as those with glaucoma, should also consult a healthcare provider.

Furthermore, patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers during nighttime use should consult a doctor or pharmacist prior to using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may take 2 capsules with water every 4 hours during the daytime and every 6 hours at nighttime. For children under 12 years, it is advised to consult a doctor before use.

Caution is warranted when administering this product, as excitability may occur, particularly in children during nighttime use.

It is essential to keep this product out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are observed.

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 adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin. Caution is recommended when driving a motor vehicle or operating machinery, especially in individuals with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions.

Patients are advised to adhere to the following precautions to minimize the risk of liver injury:

• Do not exceed 4,000 mg of acetaminophen within a 24-hour period.

• Avoid concurrent use with other medications that contain acetaminophen.

• Limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Monitoring of liver function may be warranted in patients with compromised liver function, and any signs of liver damage should be promptly evaluated by a healthcare provider.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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 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 (1-800-222-1222) 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.

Additionally, when patients are using both NIGHTTIME and DAYTIME products, healthcare providers should instruct them to carefully read the dosing instructions for each product. This ensures that patients understand the correct dosing to avoid potential complications.

Storage and Handling

The product is supplied in a tamper-evident package. Healthcare professionals should ensure that the outer package remains unopened and that the blister is intact before use. The expiration date and lot number can be found on the end flap of the packaging.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to protect the product from heat, humidity, and light to ensure its integrity and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 capsules with water every 4 hours during the daytime, with a maximum of 8 capsules in a 24-hour period. For nighttime use, the same patient group should take 2 capsules every 6 hours, also not exceeding 8 capsules within 24 hours.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is essential to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, 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 Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)