Original Night-Time

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates sore throat, headache, minor aches and pains, 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

The medication should be taken only as recommended, adhering to the overdose warning. For accurate dosing, a dose cup or tablespoon (TBSP) should be utilized.

Adults and children aged 12 years and older are advised to take 30 mL (2 TBSP) every 6 hours, with a maximum of 4 doses within a 24-hour period. When administering Night Time and Day Time formulations, the total combined doses must not exceed 4 doses in a 24-hour timeframe.

For children aged 4 to under 12 years, it is essential to consult a physician for appropriate dosing recommendations. The use of this medication is not indicated for 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), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• The product should not be used to induce sleepiness in children.

Warnings and Precautions

Failure to adhere to the following warnings and precautions may result in serious health consequences.

Imprint Integrity The product must not be used if the imprint on the shrink brand is missing or broken.

Liver Warning This product contains acetaminophen, which can lead to severe liver damage if the following conditions are met:

• An adult or child takes more than 4 doses within a 24-hour period, which is the maximum daily amount for this product.

• The product is used concurrently with other medications containing acetaminophen.

• The individual consumes 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any skin reaction occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Discontinuation Criteria Users should stop using the product and consult a doctor if any of the following occur:

• Redness or swelling is present.

• Symptoms do not improve within 7 days or are accompanied by a fever.

• Fever worsens or lasts more than 3 days.

• New symptoms develop.

• A cough persists for more than 7 days, recurs, or occurs with fever, rash, or headache lasting longer than usual. These symptoms may indicate a serious underlying condition.

Healthcare professionals are advised to monitor patients closely for these signs and symptoms to ensure safe use of the product.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum recommended dosage of four doses in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, 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. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice if they experience redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or lasts more than three days, if new symptoms develop, or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Original Night-Time (acetaminophen, dextromethorphan hydrobromide, 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 before use. The medication is not recommended for children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 30 mL (2 tablespoons) every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that should be considered when administering this medication to pediatric patients.

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 potential 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. 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than 3 alcoholic drinks per day while using this product. Given the potential for increased susceptibility to acetaminophen-related hepatotoxicity in this population, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the risk of severe liver damage. Regular monitoring of liver function tests may be warranted in patients with significant hepatic impairment.

Overdosage

In the event of an overdose, the administration of a dose exceeding the recommended amount may lead to significant health complications. It is imperative that medical assistance is sought immediately, or that a Poison Control Center is contacted without delay.

Recommended Actions

Prompt medical intervention is crucial for both adults and children, regardless of whether any symptoms are apparent. Healthcare professionals should be prepared to provide immediate care and support to mitigate potential adverse effects associated with the overdose.

Potential Symptoms

While specific symptoms of overdose may vary depending on the substance involved, the absence of noticeable signs does not preclude the possibility of serious health risks. Therefore, vigilance and prompt action are essential in all cases of suspected overdose.

Management Procedures

Upon recognition of an overdose, healthcare providers should follow established protocols for assessment and treatment. This may include monitoring vital signs, providing supportive care, and implementing specific antidotal therapies as indicated. The urgency of the situation necessitates that all healthcare professionals remain alert to the potential for overdose and act swiftly to ensure patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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 important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this medication to induce sleepiness in children. They should be instructed to discontinue use and seek medical advice if they experience redness or swelling, if symptoms do not improve within seven days, or if symptoms are accompanied by a fever. Additionally, patients should stop use and consult a doctor if a fever worsens or persists for more than three days, or if new symptoms arise.

Healthcare providers should emphasize that if a cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, patients should seek medical attention, as these may indicate a serious condition. Patients must be reminded to adhere strictly to the recommended dosage and to avoid consuming alcoholic beverages while using this product.

Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Caution should be advised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be encouraged to consult a doctor if they are on a sodium-restricted diet, have liver disease, glaucoma, a cough with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek medical advice if they have difficulty urinating due to an enlarged prostate gland, or 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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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