Antigrip Nighttime

Description

No description information is available for the 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, muscular aches, backaches, minor aches and pains, runny nose, sneezing, itching of the nose or throat, stuffy nose, itchy and watery eyes due to hay fever or other upper respiratory allergies, nasal and sinus congestion, and cough resulting from minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is one packet every 4 hours, with a maximum of 6 packets within a 24-hour period. It is imperative that the recommended dose is not exceeded.

To prepare the dosage, the contents of one packet should be dissolved in an 8 oz. glass of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If utilizing a microwave for preparation, the contents of one packet may be added to an 8 oz. glass of cool water. The mixture should be stirred briskly before and after heating to ensure proper dissolution. Care should be taken to avoid overheating the solution.

This product is not recommended for use in children under 12 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 non-prescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Use for more than 7 days for pain or 3 days for fever is contraindicated unless directed by a healthcare provider, to prevent potential adverse effects associated with prolonged use.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as within 2 weeks of discontinuing an MAOI. This is due to the risk of serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consult a healthcare professional.

• The product should not be used to sedate children, as safety and efficacy in this population have not been established.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed the maximum daily dosage of 6 packets within a 24-hour period, take this product concurrently with other medications containing acetaminophen, or consume 3 or more alcoholic beverages daily while using this product.

Patients should be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

Healthcare professionals should advise patients to stop using the product and seek medical advice if any of the following occur:

• Symptoms do not improve.

• New symptoms develop.

• Pain or fever persists or worsens.

• Redness or swelling is observed.

• Patients experience nervousness, dizziness, or sleeplessness.

• A persistent cough or symptoms last longer than 7 days, worsen, recur, or are accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

In the event of an accidental overdose, it is imperative that patients seek immediate medical attention or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 packets within 24 hours, use other medications containing acetaminophen concurrently, or consume 3 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

While using this product, drowsiness may occur, and the effects can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Patients are cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery. Additionally, excitability may be observed, particularly in children.

Patients should discontinue use and consult a doctor if symptoms do not improve, new symptoms arise, pain or fever persists or worsens, redness or swelling is present, or if they experience nervousness, dizziness, or sleeplessness. Furthermore, a persistent cough or symptoms lasting more than 7 days, worsening, recurring, or accompanied by fever, rash, or persistent headache may indicate a serious condition and warrant medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Antigrip Nighttime (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is one packet every 4 hours.

It is important to note that this medication should not be used to sedate a child. Caregivers should ensure that the product is kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or have unique safety concerns associated with the use of this product. However, it is important to note that the product may cause drowsiness, and the concomitant use of alcohol, sedatives, or tranquilizers can enhance this effect. Given that geriatric patients may be more sensitive to drowsiness, caution is advised.

Elderly patients should exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Monitoring for these effects is recommended to ensure the safety and well-being of 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 on 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 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 lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which can pose a risk of severe liver damage. Patients with compromised liver function must be particularly cautious, as taking more than 6 packets in a 24-hour period is the maximum daily amount and can lead to significant adverse effects. Additionally, concurrent use of other medications containing acetaminophen or the consumption of 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage. Monitoring of liver function is advised in patients with existing liver disease to ensure safety and prevent potential complications.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. Early intervention can significantly mitigate the risks associated with overdose and improve patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental 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 non-prescription. 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 for more than 7 days for pain relief or more than 3 days for fever unless directed by a healthcare professional. Additionally, patients should be cautioned against using 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 encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be advised not to use this product to sedate children. They should also be instructed to discontinue use and consult a doctor if their symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. Furthermore, patients should seek medical advice if they experience redness or swelling, nervousness, dizziness, or sleeplessness.

Instruct patients to stop using the product and consult a healthcare provider if they have a persistent cough or if symptoms last longer than 7 days, worsen, recur, or are accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should be made aware that this product may cause drowsiness, and the effects may be intensified by alcohol, sedatives, or tranquilizers. Therefore, they should be advised to avoid alcoholic beverages while using this product and to exercise caution when driving or operating machinery.

Excitability may occur, particularly in children, and patients should be informed of this possibility. It is essential to recommend that patients consult a healthcare provider before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as emphysema or chronic bronchitis. Patients should also be advised to seek medical advice if they have difficulty urinating due to prostate gland enlargement, if they have a persistent or chronic cough associated with smoking, asthma, or emphysema, or if a cough is accompanied by excessive phlegm.

Lastly, patients should be encouraged to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the carton and packets prior to use; do not use if they are torn or punctured.

For optimal storage, the product should be kept at room temperature, specifically within the range of 68-77°F (20-25°C). It is important to avoid exposure to excessive heat and moisture to maintain product integrity.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours, not to exceed 6 packets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)