Teeny Tummy

Description

The drug is a combination formulation containing active ingredients with a specified chemical name. It is characterized by distinct physical properties, including its color, shape, and size. The formulation details indicate the strength of the active ingredients, which contribute to its therapeutic efficacy. Inactive ingredients are included in the formulation, each serving a specific role to ensure stability and effectiveness. The drug is packaged in a designated container type, with a specified quantity per package, ensuring proper storage and distribution.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

The medication should be shaken well before use. Dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses per day.

For administration, the enclosed dropper should be filled to the recommended dosage level. The liquid should be dispensed slowly into the baby’s mouth, directed toward the inner cheek. Alternatively, the dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

After each use, the dropper must be cleaned thoroughly, and the original cap should be replaced on the bottle to maintain product integrity.

Dosage by Age and Weight:

• For infants under 2 years of age (weighing less than 24 lbs), the recommended dosage is 0.3 mL.

• For children over 2 years of age (weighing more than 24 lbs), the recommended dosage is 0.6 mL.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion and potential harm.

In the event of an overdose, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware that in the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. This warning underscores the importance of adhering to prescribed dosages to mitigate the risk of serious adverse reactions associated with overdose.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for patients to remain vigilant and report any unexpected symptoms or concerns to their healthcare provider promptly.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Teeny Tummy (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years old (weighing less than 24 lbs) are recommended to receive a dose of 0.3 mL. For children over 2 years old (weighing more than 24 lbs), the recommended dose is 0.6 mL. All dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses per day.

Healthcare professionals should ensure that the product is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific information regarding the use of TEENY TUMMY GAS RELIEF DROPS in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the administration of this medication to elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs. It is advisable to evaluate the potential risks and benefits before prescribing this medication to geriatric patients.

Pregnancy

There is no information available regarding the use of TEENY TUMMY GAS RELIEF DROPS (simethicone suspension) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

Renal Impairment

There is no specific information available 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 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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on clinical judgment and established protocols. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of any complications that may arise.

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 compound in these areas.

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. It is crucial to emphasize the importance of safety in the home environment, particularly for families with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that includes a printed seal under the cap, which must remain intact; do not use the product if this seal is broken or punctured. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. For reference, the lot number and expiration date can be found on the bottom panel of the container.

Additional Clinical Information

The medication is administered orally, with all dosages available for repetition as needed, either after meals or at bedtime, unless otherwise directed by a physician. There are no additional details regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)