Antigrip

Description

Antigrip is a formulation designed for the relief of symptoms associated with cough and cold. It is specifically indicated for the management of respiratory discomfort. The product is available in a dosage form suitable for oral administration.

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, cough due to minor throat and bronchial irritation, minor aches and pains, headache, sore throat, and it temporarily reduces fever.

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

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.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently 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 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 12 tablets within a 24-hour period. Additionally, the risk increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume three or more alcoholic drinks daily while using this product.

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 manifest, patients must discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, particularly if accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

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

• Nervousness, dizziness, or sleeplessness

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

• Fever that worsens or persists beyond three days

• Presence of redness or swelling

• Emergence of new symptoms

• Recurrence of cough, especially if accompanied by a rash or headache lasting longer than usual. These symptoms may indicate a serious underlying condition.

Accidental Overdose In the event of an accidental overdose, it is imperative to seek medical help or contact a Poison Control Center immediately. Prompt medical attention 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 12 tablets in 24 hours, use it in conjunction with other drugs containing acetaminophen, 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.

Patients should also be cautious regarding the use of this product if they experience a severe sore throat that persists for more than two days, particularly if accompanied by fever, headache, rash, nausea, or vomiting, and should consult a doctor promptly.

Common adverse reactions may include marked drowsiness and excitability, particularly in children. The sedative effects of this product may be enhanced by the consumption of alcohol, sedatives, or tranquilizers, and patients are advised to avoid alcoholic beverages while taking this product. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a breathing problem such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, or emphysema, especially if accompanied by excessive phlegm.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use. In the event of an accidental overdose, it is crucial 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 any other drug 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) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of the MAOI. This interaction may lead to serious and potentially life-threatening side 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 due to potential pharmacodynamic interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects of this medication, leading to increased drowsiness and impaired cognitive function. Monitoring for excessive sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Antigrip (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, 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

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.

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, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

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 consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function are advised to adhere strictly to the recommended dosage guidelines. Specifically, taking more than 12 tablets within a 24-hour period, using other medications that contain acetaminophen, or consuming three or more alcoholic beverages daily while using this product may significantly increase the risk of liver injury. Monitoring of liver function may be warranted in patients with existing liver disease to 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 immediate symptoms does not preclude the potential for serious adverse effects. Therefore, it is essential to ensure that patients receive appropriate evaluation and management following an overdose incident.

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 potential effects in nonclinical settings.

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, 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 marked drowsiness and that this effect can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Therefore, patients should be cautioned to avoid alcoholic beverages while taking this product.

Healthcare providers should also emphasize the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Patients should be encouraged to consult with their healthcare provider before using the medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, a persistent or chronic cough (especially if associated with smoking), asthma, or a cough accompanied by excessive phlegm.

Additionally, patients should be advised to speak with their doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored in a dry place and maintained at a temperature below 77° F (25° C) to ensure optimal stability and efficacy. Special handling requirements should be observed to prevent exposure to conditions that may compromise the product's integrity.

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)