Carolina Crud Crusher

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the loosening of phlegm (mucus) and thinning of bronchial secretions. It facilitates the drainage of bronchial tubes, enhances the productivity of coughs, and aids in the removal of bothersome mucus from the bronchial passageways. Additionally, it provides temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonfuls (10 mL) every 4 hours, with a maximum of 6 doses within a 24-hour period. For children aged 6 to under 12 years, the dosage is 1 teaspoonful (5 mL) every 4 hours, also not exceeding 6 doses in 24 hours.

For children aged 2 to under 6 years, the appropriate dosage is 1/2 teaspoonful (2.5 mL) every 4 hours, with the same maximum limit of 6 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a physician before administration.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or headache lasting longer than usual, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should exercise caution and advise patients to seek medical guidance before using this product if they experience a cough accompanied by excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a prolonged headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, and patients should refrain from using it for at least two weeks after stopping the MAOI.

Common adverse reactions may include persistent cough. Patients are advised to stop use and consult a healthcare professional if their cough lasts for more than one week, recurs, or is accompanied by fever, rash, or headache, as these symptoms could indicate a serious underlying condition.

Additionally, patients should seek medical advice before using this medication if they experience a cough that produces excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Carolina Crud Crusher (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may be administered 2 teaspoonfuls (10 mL) every 4 hours, with a maximum of 6 doses in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours, also not exceeding 6 doses in 24 hours. In children aged 2 to under 6 years, the dosage is 1/2 teaspoonful (2.5 mL) every 4 hours, with the same maximum limit of 6 doses in 24 hours. For infants and children under 2 years of age, it is advised to consult a doctor before use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation.

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

Serious side effects associated with the use of this product have been reported through voluntary channels and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, (515) 276-1586.

Patient Counseling

Healthcare providers should advise patients to keep this 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 Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than one week, returns, or is accompanied by a fever, rash, or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical attention.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. This precaution is important to ensure the safe and effective use of the medication.

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 20º C to 25º C (68º F to 77º F). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Carolina Crud Crusher, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)