Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydr...

Description

RESTORE u (NDC 57344-163-05) is a daytime non-drowsy formulation designed for the relief of severe cold and flu symptoms in adults. Each caplet contains a combination of active ingredients that serve multiple therapeutic purposes: acetaminophen acts as a pain reliever and fever reducer, phenylephrine HCl functions as a nasal decongestant, dextromethorphan HBr serves as a cough suppressant, and guaifenesin acts as an expectorant to clear chest congestion and mucus. The product is available in a package containing 24 caplets.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, nasal congestion, and cough. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. The drug also temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the total dosage should not exceed 10 caplets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• History of allergic reaction to this product or any of its ingredients, as this may lead to severe adverse reactions.

Warnings and Precautions

This product contains acetaminophen, and it is imperative to adhere to the maximum daily dosage of 10 caplets (3,250 mg acetaminophen) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Healthcare professionals should advise patients to seek medical attention promptly if a sore throat is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should consult a physician if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking the anticoagulant warfarin. It is crucial that patients do not exceed the recommended dosage while using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and consult a physician if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be advised to consult a doctor promptly 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are also cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Individuals with a known allergy to this product or any of its ingredients should avoid its use.

Before using this product, patients should seek medical advice if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional. Patients taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist prior to use.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious condition.

In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately 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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric disorders, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

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 anticoagulant effect.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 consult a healthcare professional prior to using this product. The formulation contains acetaminophen, which has specific dosing considerations for individuals with compromised liver function.

The maximum recommended daily dose of this product is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. It is critical to note that severe liver damage may occur if the total acetaminophen intake exceeds 4,000 mg in a 24-hour period. Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an increased risk of severe liver damage when using this product. Therefore, careful monitoring and adherence to the recommended dosage are essential for patients with hepatic impairment to mitigate the risk of adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including skin rash, itching, and hives. Instances of liver damage have been observed, particularly associated with excessive use of acetaminophen. Gastrointestinal disturbances, such as nausea and vomiting, have also been reported. Additionally, central nervous system effects, including dizziness and drowsiness, have been documented. Cardiovascular effects, including elevated blood pressure and palpitations, have been recorded as well.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. They should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that the return of a cough or the occurrence of a cough accompanied by a rash or persistent headache warrants immediate medical attention, as these may indicate a serious condition. It is crucial to emphasize that patients should not exceed the recommended dosage while using this product.

Before using this product, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. 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. Furthermore, patients experiencing a cough with excessive phlegm should consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product in a dry place at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions are crucial for maintaining the quality of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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