Cold and Flu

Description

Acetaminophen 650 mg, dextromethorphan HBr 30 mg, and doxylamine succinate 12.5 mg comprise the active ingredients in this formulation. The product contains 10% alcohol and is flavored with cherry. It is indicated for individuals aged 12 years and older, providing nighttime relief from symptoms associated with colds and flu. The formulation serves multiple purposes, acting as a pain reliever and fever reducer, cough suppressant, and antihistamine. It addresses symptoms such as headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. The product is designed to be tamper evident; it should not be used if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times.

For children under 12 years of age, the product is not recommended for use.

When utilizing other Day Time or Night Time products, healthcare professionals should advise patients to carefully read each label to confirm appropriate dosing and avoid potential interactions.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for 2 weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is doubt about the presence of acetaminophen in a medication, a healthcare professional should be consulted.

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 patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use. It is also essential to inquire about concurrent use of sedatives, tranquilizers, or the anticoagulant warfarin, as these may interact adversely with acetaminophen.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Discontinuation of Use Patients should be advised to stop taking this product and consult a healthcare provider if any of the following occur: worsening pain or cough lasting more than seven days, presence of redness or swelling, emergence of new symptoms, fever worsening or persisting beyond three days, or recurrence of cough accompanied by rash or headache lasting. Monitoring for these signs is essential to ensure patient safety and effective management of their 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. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

An allergy alert is warranted, as acetaminophen may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must discontinue use and seek medical assistance immediately.

Patients should also be cautious regarding the potential for excitability, particularly in children, and marked drowsiness, which may affect their ability to drive or operate machinery. The use of alcoholic beverages, sedatives, and tranquilizers may exacerbate drowsiness.

In addition, patients are advised to stop using the product and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if redness or swelling is observed, if new symptoms arise, or if fever worsens or lasts more than 3 days. A return of cough accompanied by rash or headache that lasts should also prompt medical consultation, as these may indicate a serious condition.

Lastly, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should seek prompt medical advice.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking a prescription MAOI or for a period of two weeks following the discontinuation of the MAOI treatment.

Caution is advised when this medication is used in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may occur.

It is important to note that the use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness. Monitoring for increased sedation is recommended in patients who are using these substances concurrently.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness may be experienced. In the event of an overdose, it is critical to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments for this product; however, caution is advised due to the potential for increased sensitivity to side effects. The product is intended for use in adults and children aged 12 years and older, suggesting that its safety and efficacy in geriatric patients have not been established without prior consultation with a healthcare professional.

Particular attention should be given to the risk of side effects in elderly patients, especially those related to sedatives and tranquilizers, which may exacerbate drowsiness and impair cognitive function. Therefore, careful monitoring is recommended when prescribing this product to geriatric patients.

Additionally, it is important for healthcare providers to assess any underlying conditions that may be more prevalent in elderly patients, such as liver disease, glaucoma, or urinary difficulties due to an enlarged prostate gland. Consultation with a physician is advised before initiating treatment in patients with these conditions to ensure safe and effective use.

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 on 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dose exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. In cases of overdose, which may result from exceeding the recommended dosage, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of liver damage.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of prompt evaluation and management, even in the absence of overt signs or symptoms of overdose.

Healthcare professionals should ensure that patients and caregivers are aware of these risks and the necessary steps to take in the event of an overdose, reinforcing the importance of adhering to the prescribed dosage.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Patients should be advised about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial for patients 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 in the absence of noticeable signs or symptoms.

When using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. It is important to counsel patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Patients should also be cautioned to exercise care when driving a motor vehicle or operating machinery.

Patients should be instructed to stop using the product and consult a healthcare provider if any of the following occur: pain or cough worsens or persists for more than 7 days; redness or swelling develops; new symptoms arise; fever worsens or lasts more than 3 days; or if a cough returns or occurs alongside a rash or headache that lasts.

Before using this product, patients should be encouraged to consult a healthcare provider if they have any of the following conditions: liver disease; glaucoma; a cough accompanied by excessive phlegm; a breathing problem or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema; or difficulty urinating due to an enlarged prostate gland.

Patients should also be advised to speak with a doctor or pharmacist prior to use if they are currently taking sedatives or tranquilizers, or the blood-thinning medication warfarin. Furthermore, it is imperative to inform patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should consult a healthcare provider or pharmacist. Additionally, patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription, and should seek clarification from a healthcare provider or pharmacist if they are unsure.

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 a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.

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