Antigrip

Description

No relevant information is available for SPL code 34089-3.

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, stuffy nose, nasal congestion, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive.

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 utilizing a microwave for preparation, the contents should be added to a glass of cool water and stirred briskly before and after heating, ensuring not to overheat 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 limit 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, 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, as well as within two weeks of discontinuing an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI before using this product.

• Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 6 packets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Healthcare providers should recommend that patients seek medical advice prior to using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, a persistent or chronic cough (such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema), or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before use.

In the event of an accidental overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain or nasal congestion worsens or persists beyond 7 days; if fever intensifies or lasts more than 3 days; if any new symptoms arise; or if a persistent cough or symptoms do not improve within 7 days, recur, or are accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

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 three or more alcoholic drinks daily while using this product.

Patients should seek medical advice if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Additionally, patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if pain or nasal congestion worsens or lasts more than seven days; if fever worsens or lasts more than three days; if any new symptoms arise; or if a persistent cough or symptoms do not improve within seven days, recur, or are accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough with excessive phlegm, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), or difficulty urinating due to an enlarged prostate gland.

Patients taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist prior to use.

In the event of an accidental overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Additionally, 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 alterations in the anticoagulant effect.

Packaging & NDC

Below are the non-prescription pack sizes of Antigrip (acetaminophen, dextromethorphan hbr, guaifenesin, 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 should be exercised to adhere to the specified dosing guidelines to ensure safety and efficacy in this age group.

Geriatric Use

There is no specific information available 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, 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 essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity.

The maximum recommended dosage is 6 packets within a 24-hour period. Patients with compromised liver function should be particularly vigilant not to exceed this limit, as exceeding the maximum daily amount can lead to severe liver damage. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with hepatic impairment are advised to limit alcohol consumption to fewer than 3 drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess their individual risk and determine the appropriateness of using this product. Regular monitoring of liver function may be warranted in these patients to ensure safety during treatment.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 initially 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 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 have stopped taking an MAOI within the past two weeks. Patients should be advised to verify 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 be advised to stop use and seek medical advice if they notice any redness or swelling, if pain or nasal congestion worsens or persists beyond seven days, or if fever intensifies or lasts more than three days. They should also be instructed to contact a doctor if any new symptoms arise.

Healthcare providers should inform patients that a persistent cough or symptoms that do not improve within seven days, recur, or are accompanied by fever, rash, or a persistent headache may indicate a serious condition, warranting medical evaluation.

Patients must be reminded not to exceed the recommended dosage while using this product. Furthermore, they should be encouraged to consult a doctor before use 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. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Lastly, those experiencing difficulty urinating due to an enlarged prostate gland or who are taking 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 a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, specifically within the range of 68-77°F (20-25°C), to maintain its efficacy and safety.

Healthcare professionals should ensure that the packaging remains intact; the product must not be used if the packet is punctured or torn, as this could compromise the integrity of the contents. Proper handling and storage conditions are vital to ensure the product's quality and effectiveness.

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 advise patients who are pregnant or breastfeeding to consult a health professional prior to 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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