All Nite

Description

All-Nite is a cold and flu nighttime relief formulation containing acetaminophen, dextromethorphan HBr, and doxylamine succinate. This combination serves as a pain reliever, fever reducer, cough suppressant, and antihistamine. The product is designed for comparison with the active ingredients found in VICKS® NYQUIL® COLD & FLU. All-Nite is available in a liquid dosage form, with a volume of 8 fluid ounces (237 mL) and contains 10% alcohol.

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

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize the provided dose cup for accurate measurement. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations.

The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should remind patients of the importance of not exceeding the specified dosage to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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 patients 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. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

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 contain acetaminophen concurrently, and to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance. Additionally, if a patient experiences a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, they should be advised to consult a physician promptly.

General precautions should be taken for patients with specific medical conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should seek advice from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 without delay, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a healthcare provider if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants may experience excitability, particularly in children, as well as marked drowsiness. Caution is advised when driving a motor vehicle or operating machinery, especially when combined with alcohol, sedatives, or tranquilizers, as these substances may exacerbate drowsiness.

Patients are advised to stop use and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, 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.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for acetaminophen overdose and associated hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should consult a healthcare professional prior to use. This includes individuals who have discontinued MAOI therapy within the past two weeks, as significant interactions may occur.

Caution is advised when this medication is used concurrently with warfarin, a blood-thinning agent, as it may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety and to adjust warfarin dosage if necessary.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of All Nite (acetaminophen, dextromethorphan hbr, 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 prior to use. The product is not recommended for children under 4 years of age.

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, 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

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, as exceeding this limit may lead to significant hepatic injury.

Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also result in severe liver damage. Furthermore, the consumption of three or more alcoholic drinks daily while using this product may exacerbate the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

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

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 several adverse events associated with the use of acetaminophen. Reports indicate that severe skin reactions may occur, characterized by symptoms such as skin reddening, blisters, and rash. Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical help or contacting a Poison Control Center at 1-800-222-1222 in the event of an overdose. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is essential to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. They should also be instructed to discontinue use and consult a doctor if pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be advised to seek medical attention if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. They should be cautioned to avoid alcoholic beverages while using this product and to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should be advised to speak with a doctor or pharmacist before use if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate dosing, while use is not recommended for children under 4 years.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Patients are also advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

Drug Information (PDF)

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

View product document (PDF)