Guaifed Dm

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

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 10 mL (equivalent to 2 teaspoonfuls) administered every 4 hours as needed, or as directed by a healthcare professional. It is imperative that the total number of doses does not exceed 6 doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended. Healthcare professionals should ensure that patients adhere to the specified dosage guidelines and monitor for any potential adverse effects associated with exceeding the recommended dosage.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, or if the cough returns or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

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

Warnings 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 a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

General Precautions Healthcare professionals should advise patients to seek medical consultation before using this product if they experience a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough. This includes individuals with a history of smoking, asthma, chronic bronchitis, or emphysema.

Emergency Situations In the event of an overdose, it is crucial to obtain immediate medical assistance or contact a Poison Control Center without delay.

Discontinuation of Use Patients should be instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a cough that persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, and patients should discontinue use and seek medical advice if they experience these signs.

Additionally, patients should consult a healthcare provider before using this product if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. It is essential for patients to be vigilant about their symptoms and to seek appropriate medical guidance when necessary.

Drug Interactions

The use of Guaifed DM is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for a period of two weeks following the discontinuation of an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for Guaifed DM. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 10 mL (2 teaspoonfuls).

Healthcare professionals should advise caregivers to keep this medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additional events noted are hallucinations, confusion, agitation, increased heart rate, and respiratory depression. Seizures and hepatotoxicity have also been reported, along with cases of serotonin syndrome. Furthermore, other unspecified reactions have been documented.

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 Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult a doctor prior to use if they have a cough that produces excessive phlegm (mucus). It is also important to advise patients to seek medical advice if they have a cough that is chronic or lasts for an extended period, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 15° to 30°C (59° to 86°F). Care must be taken to protect the product from freezing and from exposure to light. Additionally, it is imperative that the foil seal over the bottle opening remains intact; the product should not be used if the seal is torn, broken, or missing.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)