Delsym

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold. It is also indicated for the temporary relief of cough to facilitate sleep. Additionally, this drug provides temporary relief from minor aches and pains associated with muscles and joints.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application for cough relief involves applying a thick layer of the product to the throat and chest. If desired, the area may be covered with a warm, dry cloth to enhance the effect. It is advised that clothing around the throat and chest be loose to facilitate the release of vapors to the nose and mouth.

For the relief of muscle aches and pains, the product should be applied directly to the affected area. The application may be repeated up to three times daily or as directed by a healthcare professional.

For children under 2 years of age, it is recommended to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

Heating, microwaving, or adding the product to hot water or any container where heating water occurs is contraindicated due to the risk of splattering, which may result in burns. The product should not be taken by mouth or placed in the nostrils, as this may lead to adverse effects. Additionally, tight bandaging is contraindicated to prevent complications. Contact with the eyes must be avoided to prevent irritation or injury. The application of the product to wounds or damaged skin is also contraindicated to avoid exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only.

Healthcare professionals should advise patients to consult a physician prior to use if they have a chronic cough lasting longer than a few days, particularly if associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

When utilizing this product, it is imperative to adhere to the following precautions:

• Avoid heating, microwaving, or adding the product to hot water or any container that may heat water, as this may lead to splattering and potential burns.

• The product should not be ingested or placed in the nostrils.

• It is essential to avoid tight bandaging of the area where the product is applied.

• Contact with the eyes must be avoided.

• The product should not be applied to wounds or damaged skin.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use. Additionally, the product should be kept out of reach of children to prevent accidental ingestion.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients should discontinue use and consult a physician if any of the following occur: a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Furthermore, if muscle aches and pains worsen, persist beyond 7 days, or resolve only to recur within a few days, medical advice should be sought.

Side Effects

Patients using this product should be aware that it is intended for external use only.

In clinical practice, participants are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. Additionally, if muscle aches and pains worsen, persist beyond 7 days, or resolve only to recur within a few days, medical advice should be sought.

Before using this product, patients should inform their healthcare provider if they have a chronic cough associated with conditions such as smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

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 Delsym (camphor (natural) , eucalyptus oil, and menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For adults and children aged 2 years and older, the product is indicated for cough relief. In this age group, a thick layer should be applied to the throat and chest. The indication for use in children aged 2 years and older is clearly stated on the principal display panel.

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 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the 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

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 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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, there was no increase in fetal malformations noted in these studies. The available data do not indicate any concerns regarding teratogenicity or non-teratogenic effects in the context of the evaluated animal models.

Information regarding animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated contact number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition. Additionally, they should be cautioned to discontinue use and seek medical advice if muscle aches and pains worsen, persist for more than 7 days, or resolve only to recur within a few days.

It is important to instruct patients not to heat, microwave, or add the product to hot water or any container that may heat water, as this could cause splattering and result in burns. Patients should also be advised against taking the product by mouth or placing it in their nostrils, and to avoid bandaging tightly when using the product.

Healthcare providers should emphasize the need to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Patients should be encouraged to consult a doctor before using the product if they have a chronic cough associated with smoking, asthma, or emphysema, or 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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients may use the medication up to three times daily or as directed by a healthcare professional. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the medication is swallowed.

Drug Information (PDF)

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

View product document (PDF)