Pepcid Complete, Pepcid Complete, Travel Basix

Description

Pepcid Complete Berry is a chewable tablet formulation containing the active ingredients famotidine (10 mg), calcium carbonate (800 mg), and magnesium hydroxide (165 mg). This combination provides an effective acid reducer and antacid for the relief of heartburn associated with acid indigestion. The product is characterized by its berry flavor and is designed for convenient single-tablet dosing. It is manufactured by Lil' Drug Store.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to chew 1 tablet thoroughly before swallowing to relieve symptoms. It is imperative that the tablet is not swallowed whole; it must be completely chewed to ensure proper efficacy. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients who experience difficulty or pain when swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated due to potential interactions and increased risk of adverse effects.

Warnings and Precautions

Patients should not use this medication if they have a known allergy to famotidine or other acid reducers.

Healthcare professionals are advised to exercise caution and recommend that patients consult a physician prior to use if they have experienced heartburn for more than three months, as this may indicate a more serious underlying condition. Additionally, patients should seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; or frequent wheezing, particularly in conjunction with heartburn. Unexplained weight loss, nausea or vomiting, stomach pain, or a history of kidney disease also warrant a consultation with a healthcare provider before use.

It is important for patients to inform their doctor or pharmacist if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients are advised to discontinue use and consult their doctor if their heartburn persists or worsens, or if they find it necessary to use this product for more than 14 consecutive days.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and individuals are advised to seek medical attention if they experience any of the following symptoms: difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

Patients should not use this medication if they have a known allergy to famotidine or other acid reducers. Additionally, it is contraindicated for use in conjunction with other acid-reducing medications.

Before initiating treatment, patients are encouraged to consult a healthcare provider if they have experienced heartburn for more than three months, as this may signal a more serious condition. Other concerning symptoms that warrant medical consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; frequent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or a history of kidney disease.

Patients should discontinue use and consult a healthcare professional if their heartburn persists or worsens, or if they find it necessary to use the product for more than 14 days.

Drug Interactions

Antacids and acid-reducing agents may interact with various prescription medications, potentially affecting their absorption and therapeutic efficacy.

When co-administered with drugs that require an acidic environment for optimal absorption, antacids and acid reducers can lead to decreased bioavailability of these medications. It is advisable to monitor the clinical response of patients receiving such combinations and consider adjusting the timing of administration to minimize interaction.

Healthcare professionals should evaluate the necessity of dosage adjustments based on the specific medications involved and the clinical context of the patient. Regular assessment of therapeutic outcomes is recommended to ensure effective treatment while mitigating the risk of reduced drug efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Pepcid Complete, Pepcid Complete, Travel Basix (famotidine, calcium carbonate, magnesium hydroxide chewable tablet). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, it is important to note that the tablet must not be swallowed whole; it should be chewed completely prior to swallowing to effectively relieve symptoms. The maximum recommended dosage for this age group is 2 chewable tablets within a 24-hour period.

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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

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 at 1-800-222-1222.

Patients should be cautioned against using this medication if they experience difficulty or pain when swallowing food, vomiting blood, or passing bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical attention. Additionally, patients should not use this product in conjunction with other acid reducers.

Healthcare providers should encourage patients to discontinue use and consult a doctor if their heartburn persists or worsens, or if they find it necessary to use the product for more than 14 days. It is important to advise patients to seek medical advice if they have experienced heartburn for over three months, as this may signal a more serious condition.

Patients should also be informed to consult a doctor before using this medication if they experience heartburn accompanied by lightheadedness, sweating, or dizziness, or if they have chest pain or shoulder pain along with shortness of breath, sweating, pain radiating to the arms, neck, or shoulders, or lightheadedness. Frequent chest pain or wheezing, particularly in conjunction with heartburn, unexplained weight loss, nausea, vomiting, or stomach pain should also prompt a discussion with a healthcare provider prior to use.

Furthermore, patients with a history of kidney disease should seek medical advice before using this medication. Lastly, it is essential for patients to consult a doctor or pharmacist if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Storage and Handling

The product is supplied in pouches that must be stored at a temperature range of 20° to 25°C (68° to 77°F). It is essential to protect the product from moisture to maintain its integrity. Healthcare professionals should ensure that the pouch is not used if it is torn or damaged, as this may compromise the product's safety and efficacy.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. Adults and children aged 12 years and older should chew one tablet completely before swallowing, and should not exceed two chewable tablets within a 24-hour period. For children under 12 years, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)