Always Save Chest Congestion Relief

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a common cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication helps make coughs more productive.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that parents or guardians consult a doctor for children under 6 years of age before administration.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period unless directed otherwise by a physician. Proper adherence to these guidelines is crucial for safe and effective use of the medication.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought, as a persistent cough may indicate a serious underlying condition.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Contraindications The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Adverse Reactions Patients should discontinue use and seek medical advice if symptoms are accompanied by fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it is essential to consult a healthcare provider, as this may indicate a serious underlying condition.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the local Poison Center should be contacted without delay.

General Precautions Prior to using this product, patients should consult their healthcare provider if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Additionally, it is advisable to seek medical advice if the cough is accompanied by excessive phlegm (mucus).

No specific laboratory tests are recommended for monitoring in conjunction with the use of this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or complications in patients using this medication.

Side Effects

Patients using this product should be aware of certain warnings and adverse reactions. It is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks. Patients are advised to consult their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

In the context of over-the-counter (OTC) use, patients should discontinue use and seek medical advice if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, it may indicate a serious underlying condition, warranting further evaluation.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, bronchitis, or emphysema, should consult a healthcare professional before using this product. Furthermore, if the cough is accompanied by excessive phlegm (mucus), it is recommended that patients seek medical advice prior to use.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric or emotional conditions, and Parkinson's disease. Patients should not initiate treatment with this product while currently taking an MAOI or within 14 days following the discontinuation of an MAOI.

It is essential for patients to consult with their healthcare provider or pharmacist if they are uncertain whether their current prescription medication contains an MAOI before using this product. This precaution is critical to avoid potential serious interactions that may arise from the combination of these agents.

Packaging & NDC

Below are the non-prescription pack sizes of Always Save Chest Congestion Relief (dextromethorphan hydrobromide / guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 10 years may take 1/2 tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor before administration.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Center immediately.

Patients should be informed to discontinue use and consult their doctor if they experience symptoms such as fever, rash, or a persistent headache. Additionally, they should be cautioned to stop use and seek medical advice if their cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

It is important for healthcare providers to recommend that patients consult their doctor before using the medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Furthermore, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

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 temperature range of 15° to 30°C (59° to 86°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, with a maximum of six doses within a 24-hour period unless otherwise directed by a physician. For children aged 6 to 10 years, the dosage is half a tablet every four hours as needed, while for children under 6 years of age, consultation with a doctor is advised before administration.

Drug Information (PDF)

This file contains official product information for Always Save Chest Congestion Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)