Dolomax Cold Cough

Description

DoloMaxCold-133 is a pharmaceutical formulation designed for the management of cold symptoms. The product's specific chemical composition and structural formula are proprietary. It is available in a dosage form suitable for oral administration. The appearance of DoloMaxCold-133 is consistent with standard pharmaceutical preparations, ensuring ease of identification and use in clinical settings. Further details regarding its molecular weight and inactive ingredients are available in the complete product documentation.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 tablets every 4 hours as needed. The tablets should be swallowed whole and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that no more than 10 tablets should be taken within a 24-hour period to avoid potential overdose.

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

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to the guidelines. The maximum daily dosage is limited to 10 tablets (3,250 mg of 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, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

Contraindications and Precautions

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare provider. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have taken an MAOI within the past two weeks. Patients with a known allergy to this product or any of its ingredients should also refrain from use.

Before administering this product, healthcare professionals should inquire about the following conditions: liver disease, high blood pressure, thyroid disease, diabetes, urinary difficulties due to an enlarged prostate, and persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients experiencing a cough with excessive phlegm should also be evaluated. Furthermore, it is advisable to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

Patients must adhere strictly to the recommended dosage and should not exceed it.

Emergency Situations

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Monitoring and Follow-Up

Patients should be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that lasts should also prompt immediate medical consultation, 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 with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients should also be instructed to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; new symptoms; or a cough that returns or occurs with a rash or headache lasting. These symptoms may indicate a serious condition requiring medical evaluation.

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 conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

Patients taking blood-thinning medications, such as warfarin, should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Dolomax Cold Cough (acetaminophen, dextromethorphan hydrobromide, guaifenesin, 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 dosing is 2 tablets every 4 hours, with a maximum of 10 tablets (3,250 mg acetaminophen) in a 24-hour period.

It is important to note that in cases of 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 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. 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 the safety of both the mother and the developing fetus.

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 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with a risk of severe liver damage. The maximum daily dose for this product is 10 tablets, equating to 3,250 mg of acetaminophen within a 24-hour period.

It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this product in their treatment regimen. Regular monitoring of liver function may be warranted in these patients to prevent potential 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 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, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 keep the medication out of reach of children to prevent accidental ingestion. It is important to communicate the potential risks associated with overdose. Patients should be informed that in the event of an overdose, they must seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Additionally, healthcare providers should emphasize the necessity of quick medical attention for both adults and children in cases of overdose, even if no signs or symptoms are immediately apparent. This proactive approach can be crucial in ensuring patient safety and effective management of any adverse situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 10 tablets in a 24-hour period. Patients should swallow the tablets whole and not crush, chew, or dissolve them. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)