Antigrip

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sore throat, headache, nasal congestion, runny nose, itching of the nose or throat, stuffy nose, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

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

Dosage and Administration

One packet should be dissolved in an 8-ounce glass of hot water. If a microwave is used for heating, the contents should first be added to a glass of cool water and stirred briskly before and after heating to ensure proper dissolution. Care should be taken to avoid overheating the mixture. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes.

For adults and children aged 12 years and older, the recommended dosage is one packet every 4 hours, with a maximum of 6 packets within a 24-hour period. The 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 nonprescription, is prohibited 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.

The product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is any doubt about the presence of an MAOI in a current prescription, a healthcare professional should be consulted prior to use.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to adhere strictly to the following precautions:

Liver Warning Severe liver damage may occur if patients exceed the maximum daily dosage of 6 packets within a 24-hour period. Additionally, the risk increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product. It is essential to monitor liver function in patients who may be at risk due to these factors.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a healthcare professional promptly. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Emergency Medical Help In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation and Consultation Patients should be instructed to stop using the product and consult a healthcare provider if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Redness or swelling

• Worsening pain, cough, or nasal congestion lasting more than 7 days

• Fever that worsens or persists for more than 3 days

• Any new or unusual symptoms

• A cough that recurs or is accompanied by a rash or headache that lasts

These symptoms may indicate a serious condition that necessitates further medical evaluation. Regular monitoring and patient education on these warnings and precautions are essential for 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 if patients exceed the maximum daily dosage of 6 packets within 24 hours, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

In addition, patients should be vigilant for severe sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised to consult a doctor promptly.

While using this product, patients may experience excitability, particularly in children, and should exercise caution when driving or operating machinery due to the potential for marked drowsiness.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain, cough, or nasal congestion worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if any new symptoms arise; or if a cough returns or occurs with a rash or headache that persists. These symptoms could indicate a serious condition.

Additional considerations include the need for patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough accompanied by excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), difficulty urinating due to an enlarged prostate gland, or if they are taking sedatives or tranquilizers. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered within two weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Antigrip (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is one packet every 4 hours, with a maximum of 6 packets in a 24-hour period.

Caution is advised as the medication may cause excitability, particularly in children. In the event of an accidental overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information 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.

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 on 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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 the maximum daily amount of 6 packets within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 intervention 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, as early recognition and treatment can significantly impact patient outcomes.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with 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 within two weeks of stopping such medication, which is commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use and seek medical advice if they notice any redness or swelling, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if fever worsens or lasts more than three days. They should also be instructed to contact a healthcare provider if any new symptoms arise or if a cough recurs, particularly if accompanied by a rash or a headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. They should be made aware that the product may cause excitability, particularly in children, and that caution is advised when driving or operating machinery due to the potential for marked drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or if they have a cough accompanied by excessive phlegm. They should also seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if they experience difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to consult a doctor before use if they are taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packets that must be stored at room temperature, specifically within the range of 68-77°F (20-25°C). It is imperative that the integrity of the packaging is maintained; therefore, the product should not be used if the packet is punctured or torn.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being one packet every four hours, not to exceed six packets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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