Antigrip

Description

Antigrip Red is a pharmaceutical formulation designed for the relief of symptoms associated with colds and flu. The product is presented in a dosage form suitable for oral administration. It is characterized by its distinct red coloration, which is indicative of its active ingredients. The formulation includes a combination of components that work synergistically to alleviate discomfort and improve patient outcomes during episodes of respiratory illness.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates runny nose, sneezing, nasal congestion, minor aches and pains, headache, and temporarily reduces fever.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours as needed. The maximum dosage should not exceed 12 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription, healthcare professionals should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage and to avoid the consumption of alcoholic beverages while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to guidelines.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 12 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases when this product is taken in conjunction with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms 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 two days, or if accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

General Precautions Prior to use, individuals should consult a healthcare provider 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. Additionally, those experiencing difficulty in urination due to prostate gland enlargement should seek medical advice. It is also advisable to consult a doctor or pharmacist before use if taking blood-thinning medications such as warfarin or if using sedatives or tranquilizers.

Emergency Medical Help Instructions In the event of an accidental overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Stop Taking and Call Your Doctor Instructions Discontinue use and consult a healthcare provider if any of the following occur: nervousness, dizziness, or sleeplessness; pain or nasal congestion persists for more than seven days; fever worsens or lasts more than three days; redness or swelling is observed; or if new symptoms develop.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 12 tablets in 24 hours, use other drugs containing acetaminophen concurrently, or consume three 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.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than two days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

While using this product, patients may experience drowsiness or excitability, particularly in children. It is advised to avoid alcoholic beverages during treatment and to exercise caution when driving or operating machinery.

Patients are instructed to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion persists for more than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; or if new symptoms arise.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as emphysema or chronic bronchitis should seek medical advice. Additionally, those experiencing difficulty in urination due to prostate gland enlargement should consult a healthcare professional.

Patients taking the blood-thinning medication warfarin or sedatives/tranquilizers should also consult a doctor or pharmacist prior to use.

In the event of an accidental overdose, it is crucial 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

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson’s disease, and co-administration may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, individuals using sedatives or tranquilizers are advised to seek guidance from a healthcare provider before initiating treatment with this medication, as the combination may enhance sedative effects and lead to increased sedation or respiratory depression.

Packaging & NDC

Below are the non-prescription pack sizes of Antigrip (acetaminophen, chlorpheniramine maleate, 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 two tablets fully dissolved in a 4 oz glass of water every 4 hours, with a maximum of 12 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Caution is advised as the medication may cause excitability, particularly in children. In the event of an accidental overdose, it is crucial to seek medical assistance 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 apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or present unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution when prescribing to this population.

It is recommended that healthcare providers inquire about any pre-existing conditions in geriatric patients, including liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, respiratory issues such as emphysema or chronic bronchitis, and urinary difficulties related to prostate enlargement.

Additionally, elderly patients may exhibit increased sensitivity to side effects, particularly drowsiness and excitability. Therefore, careful monitoring for these adverse effects is advised to ensure patient safety and well-being.

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 breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed the maximum daily dosage of 12 tablets within a 24-hour period. Additionally, the risk of severe liver damage is heightened if this product is taken concurrently with other medications containing acetaminophen.

Patients with compromised liver function are advised to consult a healthcare professional prior to use, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product may also increase the risk of severe liver damage. Monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and prevent potential adverse effects.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. Early recognition and management of an overdose can significantly influence the outcome and reduce the risk of adverse effects.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. 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 to discontinue use immediately and seek medical assistance.

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, regardless of whether any signs or symptoms are present. Prompt medical attention is essential for both adults and children.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important to inform them that the medication may cause drowsiness, and they should be cautious about engaging in activities that require alertness, such as driving a motor vehicle or operating machinery.

Additionally, healthcare providers should discuss the potential for excitability, particularly in children, and recommend that patients avoid consuming alcoholic beverages while taking this product to prevent any adverse effects.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored in a dry place, maintaining a temperature below 77°F (25°C) to ensure optimal stability and efficacy. Proper storage conditions are essential to preserve the integrity of the product.

Additional Clinical Information

No further data are available.

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.

View product document (PDF)