Night Time

Description

Acetaminophen is a pain reliever and fever reducer, formulated in combination with dextromethorphan HBr, a cough suppressant, and doxylamine succinate, an antihistamine. This product is indicated for the relief of symptoms associated with cold and flu. It is presented in a cherry-flavored liquid dosage form, containing 10% alcohol. The total volume of the product is 12 fluid ounces (355 mL).

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 take the medication only as directed, adhering to the overdose warning. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. 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 medication is not indicated for use in 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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is essential for both adults and children, even in the absence of overt signs or symptoms.

Patients should be instructed to stop using the product and consult a healthcare professional if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling develops; new symptoms arise; 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 who exceed 4,000 mg of acetaminophen within a 24-hour period, 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, 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 should be cautious of marked drowsiness, which may occur, particularly when combined with alcohol, sedatives, or tranquilizers, as these substances can exacerbate drowsiness. Excitability has also been reported, especially in children. Patients are advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

Patients should discontinue 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 with liver disease, glaucoma, chronic cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, persistent cough related to smoking, asthma, or emphysema, or those on a sodium-restricted diet should consult a healthcare professional. Additionally, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 in the absence of noticeable signs or symptoms.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of 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 before using this medication. This consultation is also advised for individuals who have discontinued MAOI therapy within the past two weeks, as interactions may occur.

The concurrent use of sedatives or tranquilizers may potentiate drowsiness, necessitating caution in activities requiring alertness, such as driving or operating machinery.

Additionally, caution is advised when this medication is used alongside warfarin, a blood-thinning agent, as it may enhance the anticoagulant effect, increasing the risk of bleeding. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time (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 contraindicated in children under 4 years of age.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential adverse effects or changes in therapeutic response, given the lack of detailed information on the use of this medication in the elderly population. Adjustments to dosage or treatment regimens may be necessary based on individual patient assessments and clinical judgment.

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 drug 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 degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

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 intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely medical evaluation are crucial in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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 several adverse events reported voluntarily or through surveillance programs. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek immediate medical assistance.

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, or tranquilizers.

Further observations include the worsening of pain or cough lasting more than 7 days, and fever persisting or worsening beyond 3 days. The presence of redness or swelling, the emergence of new symptoms, or the recurrence of cough accompanied by rash or headache that persists may indicate a serious underlying condition, warranting further medical evaluation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial 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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be encouraged to ask 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 advised against its use. They should also be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. Additionally, patients should seek medical advice if new symptoms arise or if a cough returns accompanied by 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 is a possible side effect. They should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. Patients should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

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

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 must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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 of age.

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

Drug Information (PDF)

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

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