999 Cold Remedy Granular

Description

The drug is presented in a carton format, which includes detailed labeling information. The effective date of the drug insert is September 23, 2013. An image of the carton is referenced to provide a visual representation of the packaging.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, hay fever, or other upper respiratory allergies. The symptoms alleviated by this medication include minor aches and pains, headache, sneezing, muscular aches, itchy and watery eyes, sore throat, runny nose, fever, and itching of the nose or throat.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 1 capsule three times a day. For children under 8 years of age, it is recommended to consult a healthcare professional prior to use to determine appropriate dosing and safety considerations.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following precautions:

• Keep out of reach of children to prevent accidental ingestion.

• In the event of an overdose, seek immediate medical assistance or contact a Poison Control Center.

• Discontinue use and consult a healthcare professional if pain or fever persists or worsens.

• Cease use and seek medical advice if redness or swelling occurs.

• Consult a doctor if symptoms last longer than 7 days.

• Stop use and seek medical attention if new symptoms arise, such as rash, nausea, or vomiting.

Warnings and Precautions

Patients should not use this medication if pain persists for more than 10 days or if fever lasts longer than 3 days. These durations are critical indicators that warrant further medical evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. This is essential for both adults and children, as prompt medical attention is crucial even in the absence of noticeable signs or symptoms.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: pain or fever persists or worsens; redness or swelling is observed; symptoms continue for more than 7 days; or if new symptoms arise, including rash, nausea, or vomiting. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention and include the following: patients should discontinue use and consult a doctor if pain or fever persists or worsens, if redness or swelling is present, if symptoms last for more than 7 days, or if new symptoms occur, such as rash, nausea, or vomiting.

Warnings indicate that the medication should not be used if pain lasts more than 10 days or if fever lasts more than 3 days.

In clinical practice, it is advised that patients with specific pre-existing conditions consult a healthcare professional prior to use. These conditions include glaucoma, breathing problems such as emphysema or chronic bronchitis, and difficulty in urination due to enlargement of the prostate gland. Additionally, patients who are taking sedatives or tranquilizers should seek medical advice before using this medication.

Overall, careful monitoring and consultation with healthcare providers are recommended to mitigate potential adverse reactions and ensure safe use of the medication.

Drug Interactions

The concomitant use of sedatives or tranquilizers with this product may enhance drowsiness, necessitating caution in activities requiring alertness. It is advisable to monitor patients for increased sedation and consider dosage adjustments of the sedative or tranquilizer as appropriate.

Additionally, the use of this product in combination with alcohol, sedatives, or tranquilizers may lead to increased excitability, particularly in pediatric populations. Clinicians should be vigilant in assessing the behavioral responses of children when these substances are co-administered.

No specific drug or laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of 999 Cold Remedy Granular (acetaminophen, chlorpheniramine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 8 years of age should consult a healthcare professional prior to use. Caution is advised as the medication may cause excitability, particularly in children.

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 adverse effects or changes in therapeutic response, 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 important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should evaluate the individual circumstances of each patient to ensure the safety of both the mother and the fetus or nursing infant.

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 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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise caution when administering this medication.

Should an overdosage occur, the following general recommendations should be considered:

Recommended Actions Healthcare professionals are advised to monitor the patient closely for any signs of adverse effects. Immediate medical attention should be sought in the event of suspected overdosage.

Potential Symptoms While specific symptoms of overdosage are not detailed, it is prudent to be aware of common signs associated with excessive dosing of similar medications. These may include, but are not limited to, increased severity of known side effects, altered mental status, and physiological disturbances.

Management Procedures In cases of suspected overdosage, supportive care is paramount. This may involve symptomatic treatment and monitoring of vital signs. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on further management strategies.

Healthcare professionals should document any instances of overdosage and report them to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. The substance may induce excitability, particularly in children, and drowsiness may occur when used in conjunction with alcohol, sedatives, or tranquilizers.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include drowsiness, excitability—particularly noted in children, rash, nausea, and vomiting.

Additionally, it is emphasized that prompt medical attention is critical for both adults and children in the event of an overdose, even if no signs or symptoms are immediately apparent.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to monitor their symptoms closely and to report to their healthcare provider if pain or fever persists or worsens. They should also be informed to seek medical advice if they notice any redness or swelling, if symptoms last longer than 7 days, or if new symptoms such as rash, nausea, or vomiting occur.

Healthcare providers should make patients aware that the medication may cause excitability, particularly in children, and that drowsiness may occur, especially when used in conjunction with alcohol, sedatives, or tranquilizers. Patients should be cautioned to use care when driving a motor vehicle or operating machinery.

It is essential for patients to consult their healthcare provider before using the medication if they have glaucoma, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, or if they are currently taking sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to protect the product from light and excessive heat to maintain its efficacy. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be stored in a dry place to avoid moisture-related issues. Proper adherence to these storage conditions is crucial for ensuring the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 999 Cold Remedy Granular, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)