Pepcid Complete

Description

Pepcid® Complete® is a dual-action formulation combining famotidine, an acid reducer, with antacid components. Each chewable tablet contains 10 mg of famotidine, 800 mg of calcium carbonate, and 165 mg of magnesium hydroxide. This combination is designed to relieve heartburn associated with acid indigestion effectively. The product is presented in a berry flavor and is packaged in a box containing 20 individual packets, each containing one chewable tablet.

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 advised to chew 1 tablet completely before swallowing to relieve symptoms. It is important that the tablet is not swallowed whole. The maximum recommended dosage is 2 chewable tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician before administration.

Contraindications

Use is contraindicated in patients who experience 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 requiring medical evaluation. Additionally, concurrent use with other acid-reducing medications is contraindicated due to the potential for 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.

The use of this medication is contraindicated in individuals experiencing 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 immediate medical attention.

Healthcare professionals should advise patients to consult a physician prior to use if they have experienced heartburn for more than three months, as this may suggest a more serious condition. Additionally, patients should seek medical advice if they experience heartburn accompanied by lightheadedness, sweating, or dizziness; chest 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, vomiting, stomach pain, or a history of kidney disease also warrant a discussion with a healthcare provider before initiating treatment.

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

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.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to discontinue use and consult a healthcare professional 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 also seek medical advice prior to using this medication if they have experienced heartburn for more than three months, as this may signal a more serious condition. Additional symptoms that warrant 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.

Common adverse reactions may include persistent heartburn that continues or worsens, necessitating a consultation with a healthcare provider. Patients are also advised not to use this medication for more than 14 days without medical guidance. Furthermore, individuals with known allergies to famotidine or other acid reducers should avoid using this product, as well as those who are currently taking other acid-reducing medications.

Drug Interactions

Antacids and acid-reducing agents may interact with specific prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of administration when these agents are used concurrently with other drugs. Patients should be counseled to separate the dosing of antacids or acid reducers from the administration of other medications to minimize the risk of interaction. Adjustments in dosage or additional monitoring may be necessary based on the specific drugs involved and the clinical context.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For patients aged 12 years and older, it is important to chew the tablet completely before swallowing to effectively relieve symptoms. The maximum dosage for this age group is limited to 2 chewable tablets within a 24-hour period. Specific dosing and safety information for children under 12 years is not available, emphasizing the necessity of medical consultation prior to administration.

Geriatric Use

There is no specific information regarding the use of PEPCID COMPLETE 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 efficacy and potential adverse effects is recommended in this population, given the lack of targeted data.

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 healthcare 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 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 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 symptoms may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and efficacy during the management of an overdose.

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

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 immediately or contact a Poison Control Center 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 evaluation. Additionally, patients should be informed not to 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. Patients should also be advised to seek medical advice if they find it necessary to use this product for more than 14 days.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication if they have experienced heartburn for over three months, as this may signal a more serious condition. Patients should also be advised to seek medical attention if they experience heartburn accompanied by lightheadedness, sweating, dizziness, chest pain, or shoulder pain, particularly if these symptoms are associated with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders.

Patients should be encouraged to discuss any frequent chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, stomach pain, or existing kidney disease with their healthcare provider prior to using this medication. Furthermore, patients taking prescription medications should be advised to consult their doctor or pharmacist, as antacids and acid reducers may interact with certain prescription drugs.

Storage and Handling

The product is supplied in pouches that must be stored at a temperature range of 20°-25°C (68°-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 efficacy and safety.

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, consultation with a doctor is advised prior to use.

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

Drug Information (PDF)

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

View product document (PDF)