Theraflu Nighttime

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Theraflu Nighttime

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Theraflu Nighttime

Quick Facts

Property Description
Active Ingredients Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Form Powder for oral solution (Hot Liquid)
Pharmacological Class Analgesic, Antipyretic, Antihistamine, Nasal Decongestant
Common Use Temporary nighttime relief of cold and flu discomfort
Origin Synthetic chemical compounds

What Type of Medicine is Theraflu Nighttime?

Theraflu Nighttime is defined as an Over-The-Counter (OTC) combination drug and a Multi-ingredient Cough and Cold product (MICC), intended for adult use and designed specifically for nighttime symptom relief. Its fundamental identity is rooted in its comprehensive pharmacological class, which integrates the actions of an analgesic, antipyretic, antihistamine, and nasal decongestant into a single formulation. This type of preparation is derived from synthetic chemical entities, offering a multi-target approach to managing the discomforts of upper respiratory tract illness.


Active Ingredients and Dosage Form

The product's efficacy is based on three key Active Pharmaceutical Ingredients (APIs): Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride. Acetaminophen is clinically recognized worldwide for its pain-relieving and fever-reducing properties. Diphenhydramine serves as a first-generation antihistamine, contributing to the relief of symptoms like sneezing and runny nose.

This medicine is uniquely marketed as a powder for oral solution, requiring dissolution in hot liquid prior to administration via the oral route. This formulation contrasts with conventional tablets or capsules by offering the practical benefit of rapid absorption and the palliative comfort of a warm beverage, a characteristic feature of the brand.


What is the General Purpose of This Combination Drug?

The general purpose of this combination drug is to provide comprehensive, simultaneous temporary relief from the acute symptoms most likely to disrupt sleep during a cold or flu. By uniting ingredients that address fever and minor aches with components that mitigate nasal congestion and histamine-related symptoms, the formulation ensures the multi-action support is tailored to an evening-use scenario. This design minimizes symptomatic disruption, assisting the patient's ability to rest during recovery from upper respiratory tract symptoms.

Regulatory References

  1. DailyMed Label for Theraflu Nighttime Severe Cold and Cough
  2. NIH Monograph on Acetaminophen

What side effects are possible with Theraflu Nighttime?

Possible side effects and safety information

The medicine's safety profile is a composite of its three active ingredients: Acetaminophen, Diphenhydramine, and Phenylephrine. Adverse reactions are categorized by frequency and the body system affected, as defined in official regulatory documents.

Official Adverse Reactions by System-Organ Class

The official labeling organizes possible side effects into System-Organ Classes ( SOC). Nervous System Disorders are frequently reported, including common effects such as drowsiness, sedation, and dizziness, primarily linked to the antihistamine component. Gastrointestinal Disorders may involve nausea, vomiting, or dry mouth. The decongestant component may be associated with Cardiac and Vascular Disorders, such as palpitations and hypertension (increased blood pressure).

Serious Safety Considerations

Official regulatory documents emphasize the potential for serious adverse reactions. The most critical safety risk is severe hepatotoxicity ( liver damage), primarily associated with the Acetaminophen component, particularly when maximum daily doses are exceeded. Rare but severe skin reactions (such as SJS and TEN) and anaphylaxis (severe allergic reaction) are also documented concerns.

Population and Exposure Constraints

Regulatory safety statements identify certain groups and conditions where use requires specific consideration. Older adults may experience increased sensitivity to effects like sedation and urinary retention. The label imposes a strict limit on total daily Acetaminophen exposure to mitigate the risk of liver toxicity. Furthermore, official safety documents advise that the risk of central nervous system effects and liver damage is increased when alcohol is consumed concurrently with this medicine.

Overdose and Emergency Response

Overdose and when to seek help

The following information details the officially documented signs of overdose and regulator-mandated emergency actions for this multi-component product.


Documented Overdose Manifestations

System Official Regulatory Statements
Hepatic Nausea, Vomiting, Loss of Appetite, Abdominal Pain, and Jaundice. These signs may be delayed, sometimes appearing several days after ingestion.
CNS/Cardio Confusion, Hallucinations, Agitation, Tremor, Fast or uneven heart rate, and Dangerously High Blood Pressure.

Life-Threatening Outcomes and Required Actions

The primary severe outcome associated with this medicine's components is Acute Liver Failure and Death due to excessive Acetaminophen exposure. Severe skin reactions, including blistering and rash, are also documented.

Emergency Response Mandate

Official regulatory documents require that patients contact a Poison Control Center or seek immediate medical attention right away in the event of a suspected overdose. This directive is critical for both adults and children, even if no signs or symptoms are immediately apparent. Individuals with pre-existing conditions, such as chronic alcoholism or liver disease, are noted to be at increased risk for severe hepatic damage. Treatment protocols for the pain reliever component involve the time-sensitive administration of the documented antidote, N-acetylcysteine, supported by laboratory monitoring of hepatic function.

Therapeutic Uses of Theraflu Nighttime

What Theraflu Nighttime Treats: Main Uses and Benefits

The primary therapeutic benefit of this combination medicine is providing simultaneous symptomatic support across the main discomforts of the common cold and flu. It is applied across domains where acute symptoms lead to temporary functional strain, and contributes to easing the overall symptom load. The product is indicated for the temporary relief of symptoms due to the common cold.


This formulation is used for managing the widespread discomfort associated with acute illness, including fever, headache, minor body aches, nasal congestion, stuffy nose, runny nose, and sneezing. It is relevant for managing symptom clusters that interfere with daily comfort. The overall therapeutic goal is supportive, as “it assists with maintaining functional stability” during difficult symptomatic periods.

Quick Fact: Relief for Multi-Symptom Disruption

Domain Targeted Symptoms Practical Benefit
Systemic Fever, headache, body aches May help patients cope more steadily with symptom fluctuations.
Airway Congestion, stuffy nose, runny nose May assist with temporary relief of nasal blockage and discharge.
Context Symptoms that disrupt sleep Supports the patient during difficult episodes by easing distress.

Regulatory References

  1. DailyMed official drug label data

Eligibility and Restrictions for Use

Theraflu Nighttime is regulated for use primarily based on age, existing medical conditions, and concurrent medication. Use is approved for adults and children 12 years of age and over.


Contraindicated Populations

Official labeling strictly prohibits use by the following groups:

  • Children under 12 years of age.
  • Patients currently taking a Monoamine Oxidase Inhibitor (MAOI) or within 14 days of stopping an MAOI, due to the risk of a severe reaction.
  • Patients with severe liver disease (due to the Acetaminophen component).
  • Individuals with a known allergy to any of the active ingredients.

Conditions Requiring Professional Consultation

Patients with certain chronic conditions must consult a healthcare professional before use (conditional eligibility):

Condition Category Examples (as per label)
Cardiovascular/Metabolic Heart disease, high blood pressure, thyroid disease, diabetes.
Respiratory Asthma, chronic lung disease, chronic cough.
Ocular/Urological Glaucoma, trouble urinating due to an enlarged prostate gland.

Pregnancy and Lactation: The label mandates consulting a health professional before use if pregnant or breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This product's regulatory profile defines specific restrictions and interaction patterns documented by health authorities, stemming from its active ingredients: Acetaminophen, Diphenhydramine, and Phenylephrine.

Formal Regulatory Restrictions

Co-administration is formally prohibited with several substance categories. This includes Monoamine Oxidase Inhibitors (MAOIs), which must not be used for two weeks after stopping the MAOI drug. Furthermore, the label strictly prohibits co-administration with any other product containing Acetaminophen or Diphenhydramine, including those used on the skin.

Pharmacodynamic and Metabolic Interactions

Pharmacodynamic interactions may cause an additive effect, resulting in increased drowsiness when co-administered with alcohol or other Central Nervous System (CNS) Depressants, such as sedatives and tranquilizers. Separately, MAOIs are documented to augment the pressor effect of the Phenylephrine component due to inhibition of its metabolism. This pressor effect may also be potentiated when co-administered with oxytocic drugs.

Population and Substance Considerations

A label warning regarding the risk of severe liver damage is stated for patients who consume three or more alcoholic drinks daily due to the Acetaminophen component. The label also contains notes for specific populations, including the presence of phenylalanine for phenylketonurics (PKU). Consultation about use with the blood thinning drug Warfarin is also advised in official labeling.

Mechanism of Action

How Theraflu Nighttime Works

Theraflu Nighttime combines three pharmacologically distinct agents to modulate physiological pathways. The first agent, Acetaminophen, operates primarily within the central nervous system. Its mechanism involves the inhibition of cyclooxygenase (COX) activity, leading to a diminished synthesis of prostaglandins, particularly within the hypothalamic thermoregulatory center, which results in the resetting of the central temperature set point. This compound also modulates descending serotonergic pathways associated with nociception.

The second agent, Diphenhydramine, acts as a first-generation inverse agonist at H1 histamine receptors. By blocking the binding of histamine to these receptors on target cells, it inhibits the histamine-mediated increase in capillary permeability and glandular secretion. Additionally, it exerts an effect on the central nervous system's medullary cough center, altering the cough reflex arc. The third component, Phenylephrine, functions as a direct agonist of alpha1-adrenergic receptors expressed on vascular smooth muscle, leading to arteriolar and venular vasoconstriction within the nasal mucosa.

Dosage and Administration Information

How to Use Theraflu Nighttime

This section describes the administration and dosing principles for Theraflu Nighttime (Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl), defining its standard use.


Administration and Dosage Regimen

Parameter Instruction
Route of administration The medicine is administered via the oral route.
Standard Dosing The single dose for adults and adolescents is one packet of the powder for oral solution.
Frequency and Schedule Doses are taken every 4 hours as needed while symptoms persist, but only for nighttime use.
Maximum Daily Limit The total intake is strictly limited; do not take more than five packets in a 24-hour period.

Preparation and Procedural Use

Preparation requirements mandate that the entire contents of one packet be dissolved in 8 oz. of hot water, requiring the solution to be stirred until fully dissolved. The preparation is intended to be sipped while hot and consumed completely within a 10 to 15-minute timeframe.

The product is approved for use only by adults and children 12 years of age and over; its use is contraindicated in younger pediatric patients. The protocol is defined as a short-term treatment, intended to be used only for the duration of symptoms. Adherence to the minimum 4-hour interval between doses is essential and applies even when switching from a related multi-symptom (daytime) product to the nighttime formulation.

This protocol ensures a standardized approach to the oral delivery of the combination drug, adhering to the established constraints for its ingredients.

Recent Clinical Evidence

Theraflu Nighttime: Recent Clinical Evidence

Clinical research has focused on the efficacy and safety profiles of the three primary components in Theraflu Nighttime formulations: Acetaminophen, Diphenhydramine, and Phenylephrine (or Pheniramine Maleate in some variants). The majority of evidence is derived from studies evaluating these individual agents or similar combination products in treating common cold and flu symptoms.


Overview of Combination Research

Studies examining cold and flu symptom relief often utilize instruments like the Jackson Total Symptom Score (JTSS) to quantify changes in severity. Research has explored whether the combination of active ingredients in Nighttime formulations is associated with short-term improvements in symptoms such as fever, minor pain, cough, and nasal congestion in adults with an upper respiratory tract infection.

Component-Specific Findings

  • Acetaminophen (Pain Reliever/Fever Reducer): Clinical data consistently support acetaminophen's role in the temporary reduction of fever and relief of minor aches, pains, and headache associated with cold and flu.
  • Diphenhydramine (Antihistamine/Cough Suppressant): Studies have evaluated the effects of diphenhydramine, a first-generation antihistamine, on allergic symptoms like runny nose, sneezing, and watery eyes. Research has also assessed its capacity to temporarily control cough due to minor throat irritation and its known potential to induce drowsiness, a factor often considered for nighttime use.
  • Phenylephrine (Nasal Decongestant): Clinical evaluations of phenylephrine concentrate on its action as a decongestant, examining its effect on nasal passage swelling and stuffiness.

Frequently Asked Questions (FAQ)

Common questions about Theraflu Nighttime (FAQ)


Q: Is the 'Nighttime' formula different from the 'Daytime' formula?

A: Yes, official product information indicates that Nighttime and Daytime formulas typically have different active ingredients. The Nighttime product contains an antihistamine like diphenhydramine, which is associated with making you drowsy. The Daytime product is designed to be non-drowsy and omits this sedating component.


Q: How long do the effects of Theraflu Nighttime usually last?

A: Official drug directions specify that a dose is generally taken every four to six hours while symptoms persist. This scheduled interval reflects the estimated duration of action for the combination of active ingredients in the product.


Q: Is Theraflu Nighttime similar to NyQuil?

A: Theraflu Nighttime is classified as a multi-symptom cold product intended for evening use. According to regulatory sources, this product, along with similar formulations, typically combines a pain reliever/fever reducer, an antihistamine, and a cough suppressant. You can refer to the official drug labels for specific ingredient comparisons.


Q: Can Theraflu Nighttime be used for allergies?

A: The drug is officially indicated for the temporary relief of cold and flu symptoms. However, one of the active components is Diphenhydramine, which is classified as an antihistamine and is widely described as relieving common symptoms like sneezing and runny nose associated with both the common cold and allergies.


Q: Can I take Theraflu Nighttime if I am taking certain antidepressants (like SSRIs or MAOIs)?

A: Official drug information strictly prohibits taking this product with or within two weeks of stopping a Monoamine Oxidase Inhibitor (MAOI). Patients taking other types of antidepressants, such as SSRIs, should consult a healthcare professional. These medications are noted for potential interaction with the drug's components.


Q: Is Theraflu Nighttime addictive?

A: The active ingredients in this Over-The-Counter (OTC) medicine—Acetaminophen, Diphenhydramine, and Phenylephrine—are not classified as controlled substances. Official classifications suggest a low risk for abuse or dependence.


Q: Are there any common foods or drinks that interact with Theraflu Nighttime?

A: The official drug label contains a strict warning regarding alcohol consumption. It states that severe liver damage may occur if the product is taken while consuming three or more alcoholic drinks daily. No specific non-alcoholic food interactions are formally prohibited on the label.


Q: Can Theraflu Nighttime be taken on an empty stomach?

A: Official drug labels describe the method of administration (dissolving the powder in hot water), but they do not typically mandate taking the product with food. Some sources describe that taking the product with food or milk may help address potential stomach upset.


Q: Does the package insert mention any specific interactions with supplements like St. John's Wort?

A: The official label usually lists interactions with other medicines but does not typically include a comprehensive list of specific herbal supplements. Consultation with a healthcare professional regarding all current supplements is recommended.


Q: Can Theraflu Nighttime be used to help with sinus pressure?

A: The product is indicated for the temporary relief of nasal congestion. The decongestant component works by narrowing the blood vessels in the nasal passages, which helps reduce swelling and is a key action in relieving the feeling of sinus pressure.


Q: Does Theraflu Nighttime cause anxiety or nervousness?

A: The official product information advises patients to stop use and consult a healthcare professional if side effects such as nervousness or sleeplessness occur. These effects are documented potential side effects associated with the decongestant component (Phenylephrine).


Q: Can people with liver problems use Theraflu Nighttime?

A: Official labeling strictly prohibits use by patients with severe hepatic impairment or severe active liver disease due to the acetaminophen component. Patients with pre-existing liver conditions are advised to consult a healthcare professional before use.


Q: Is Theraflu Nighttime available in non-liquid forms?

A: While this specific product is packaged as a powder for oral solution, the Theraflu brand includes other multi-symptom cold formulations. These alternatives are available in various dosage forms, such as caplets or soft chews.


Q: Does Theraflu Nighttime contain any sugar or artificial sweeteners?

A: The official regulatory documents list the inactive ingredients, which may include various sweeteners, such as sugar or artificial sweeteners like sucralose. Additionally, the label notes the presence of phenylalanine in some versions for those with the condition phenylketonuria (PKU).


Q: Is Theraflu Nighttime considered an opioid?

A: No. The active ingredients are Acetaminophen (pain reliever), Diphenhydramine (antihistamine/cough suppressant), and Phenylephrine (decongestant). These ingredients are not classified by regulatory bodies as opioid drugs.


Q: What research themes are commonly discussed regarding the phenylephrine component?

A: Research themes for phenylephrine, according to authoritative sources, focus primarily on its effectiveness as an oral nasal decongestant. Other areas of discussion include its potential to cause cardiovascular effects, such as increased heart rate or blood pressure, due to its action on alpha1-adrenergic receptors.


Q: Is the active cough ingredient the same in all formulations?

A: No. While the primary Nighttime product uses Diphenhydramine as a cough suppressant, other formulations within the brand may use a different ingredient. For example, some 'Max Strength' or 'ExpressMax' products may use Dextromethorphan HBr for cough suppression.


Q: What kind of cough is Theraflu Nighttime intended to help with?

A: The official indications state that the product is intended for the temporary relief of cough. Specifically, it helps cough due to minor throat and bronchial irritation, which is a common discomfort associated with cold and flu symptoms.


Q: Why is Theraflu Nighttime not approved for children under a certain age?

A: The contraindication for use in children under 12 is based on safety reviews by regulatory bodies. These reviews indicated a lack of demonstrated effectiveness in very young children and identified risks of serious side effects from ingredients like decongestants and antihistamines in this age group.


Q: Why do people sometimes feel restless instead of sleepy after taking Theraflu Nighttime?

A: Although the medicine is intended to cause drowsiness, official drug information notes that excitability or restlessness can occur as a potential side effect. This paradoxical effect is documented for all users but is sometimes more prominent, particularly due to the stimulant effect of the decongestant component.


Q: Why do official documents advise caution when driving after taking this medicine?

A: The official drug label includes a precautionary statement advising patients to be careful when operating a motor vehicle or machinery. This warning is necessary because the medicine contains an antihistamine, which is known to cause marked drowsiness and impair attention.


Q: How does the antihistamine in Theraflu Nighttime relate to cold symptoms?

A: The antihistamine component (Diphenhydramine) works by blocking receptors for histamine, a natural compound released during illness. This action helps temporarily relieve cold symptoms that are mediated by histamine, such as runny nose, sneezing, and watery eyes.


Q: Are there any long-term effects described in research for the ingredients in Theraflu Nighttime?

A: The official labeling states that this is a product intended for short-term use, and patients are advised not to use it continuously for long periods. Consequently, most published data and official information focus on the safety and efficacy of the ingredients during temporary use for acute symptoms.


Q: Is the safety profile of Theraflu Nighttime reviewed periodically by regulatory bodies?

A: Yes. Regulatory agencies continuously monitor the safety and effectiveness of Over-The-Counter (OTC) products and their active ingredients. This surveillance may lead to updates in the drug monographs, which results in changes to warnings or labeling to ensure ongoing patient safety.


Q: What are some common mild side effects people report with Theraflu Nighttime?

A: Commonly reported side effects listed in official documents, primarily linked to the antihistamine component, include drowsiness, dizziness, dry mouth, blurred vision, and upset stomach.


Q: Can you take Theraflu Nighttime if you have high blood pressure?

A: Official labeling requires patients with certain pre-existing conditions, including high blood pressure, to consult a healthcare professional before use. This requirement exists because the medicine contains a decongestant (Phenylephrine), which can increase blood pressure due to its effects on blood vessels.


Q: Why do people with glaucoma advised to use caution with this medicine?

A: Glaucoma is listed as a condition that requires consulting a healthcare professional before using the product. This caution is due to the antihistamine component, which has effects that may potentially worsen certain types of glaucoma.


Q: Can a person with diabetes use Theraflu Nighttime?

A: Diabetes is listed as a condition that requires consultation with a healthcare professional prior to use. This is important because the drug can contain ingredients like sugar or other sweeteners that may impact blood glucose levels.


Q: Is it normal to feel a dry mouth or nose after taking Theraflu Nighttime?

A: Yes, dry mouth is listed in the official documents as a possible adverse reaction. A dry mouth or nose is a recognized effect associated with the class of medication used as the antihistamine component in the nighttime formula.

How should Theraflu Nighttime be stored and disposed of?

The official labeling for Theraflu Nighttime specifies precise conditions for product storage and handling to maintain stability and safety.

Official Storage Requirements

Requirement Classification
Temperature Store at controlled room temperature (20 C to 25 C or 68 F to 77 F).
Protection Protect from heat and moisture. Avoid excessive heat.
Liquids (Constraint) Do not refrigerate syrup formulations.

Handling and Disposal

The product must be kept out of reach of children. The container should be kept in a dry place, and the sealed packet must be unbroken when first used. The stability of the product is maintained until the labeled expiration date when stored under these conditions.

For disposal, unused or expired product should be discarded according to local regulations, as this over-the-counter medicine is not classified as a controlled substance requiring specific hazardous waste handling.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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