Pepcid Complete

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of heartburn associated with acid indigestion and sour stomach. It is intended for use in adults and pediatric patients as directed.

Dosage and Administration

Adults and children aged 12 years and over are instructed to chew 1 tablet completely before swallowing to relieve symptoms. It is essential 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 advised to consult a physician before administration.

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.

Warnings and Precautions

Use of this medication is contraindicated in individuals with a known allergy to famotidine or other acid-reducing agents.

Patients should refrain from 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 immediate medical attention.

This medication should not be used concurrently with other acid reducers, as this may increase the risk of adverse effects.

Healthcare professionals should advise patients to consult a doctor 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 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 have a history of kidney disease.

Patients taking prescription medications should consult a doctor or pharmacist before using this product, as antacids and acid reducers may interact with certain prescription drugs.

If heartburn persists or worsens, or if the product is needed for more than 14 days, patients should discontinue use and consult a doctor.

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 not to use the medication if they are allergic to famotidine or other acid reducers. Additionally, the medication should not be used in patients experiencing difficulty or pain when swallowing food, vomiting with blood, or having bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical attention.

Patients are encouraged to consult a healthcare professional before using this medication 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 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 seek medical advice if their heartburn persists or worsens, or if they find it necessary to use the product for more than 14 days. Furthermore, it is important for patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids and acid reducers may interact with certain drugs.

Drug Interactions

Antacids and acid-reducing agents may interact with various 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. Specifically, antacids can alter gastric pH, which may impact the solubility and subsequent absorption of certain medications.

Healthcare professionals should consider advising patients to separate the administration of antacids or acid reducers from other medications by at least two hours to minimize the risk of interaction. Regular monitoring of therapeutic outcomes may be warranted to ensure the effectiveness of the prescribed therapy when these agents are used together.

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 healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

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. 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. 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 on 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 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 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 timely medical support 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

If pregnant or breast-feeding, it is advised to consult a health professional before 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 are available in the extracted data. 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 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. Patients should also be informed that if they find themselves needing to use this product for more than 14 days, they should seek medical advice.

It is important for healthcare providers to ask patients about their heartburn history. Patients who have experienced heartburn for over three months, or who have heartburn accompanied by lightheadedness, sweating, or dizziness, should be advised to consult a doctor. Furthermore, patients should be instructed to seek medical attention if they experience 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, should also prompt a discussion with a healthcare provider.

Patients should be encouraged to seek medical advice if they experience unexplained weight loss, nausea, vomiting, or stomach pain. Those with a history of kidney disease should consult a doctor before using this medication. Lastly, patients taking prescription medications should be advised to consult a doctor or pharmacist, as antacids and acid reducers may interact with certain prescription drugs.

Storage and Handling

The product is supplied in packaging that includes an NDC number for identification. It should be stored at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is essential to protect the product from moisture to maintain its integrity. Additionally, the product must not be used if the foil inner seal, which is imprinted with "Sealed For Your Safety," is broken or missing, as this indicates potential compromise of the product's 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, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to seek medical advice if they have experienced heartburn for more than three months, as this may indicate a more serious condition. Additionally, patients taking prescription medications should consult a doctor or pharmacist, as antacids and acid reducers may interact with certain drugs. Pregnant or breastfeeding individuals are also encouraged to consult a health professional before use. It is important to keep the medication out of reach of children, and in the event of an overdose, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

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)