Pepcid Complete

Description

No description information is available.

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 advised to chew 1 tablet completely before swallowing to relieve symptoms. It is important to note that the tablet should not be 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 agents 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.

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 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 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 consultation with a healthcare provider before initiating treatment.

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 seek medical advice.

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 product if they experience difficulty or pain when swallowing food, vomiting with blood, or the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition that requires immediate medical attention.

Patients with a history of heartburn lasting more than three months, or those experiencing heartburn accompanied by lightheadedness, sweating, or dizziness, should consult a healthcare professional prior to use. Additionally, individuals presenting with chest pain or shoulder pain alongside symptoms such as shortness of breath, sweating, pain radiating to the arms, neck, or shoulders, or lightheadedness should seek medical advice. Frequent chest pain, wheezing—especially when associated with heartburn—unexplained weight loss, nausea, vomiting, stomach pain, or a history of kidney disease are also conditions that warrant consultation with a healthcare provider before using this medication.

Common adverse reactions may include persistent heartburn or a worsening of symptoms. Patients are advised to discontinue use and consult a healthcare professional if their heartburn continues or worsens, or if they find it necessary to use the product for more than 14 days. Furthermore, the use of this medication is contraindicated with other acid reducers, and patients should refrain from using it if they have known allergies to famotidine or other acid-reducing agents.

Drug Interactions

Antacids and acid reducers have the potential to interact with certain prescription medications. The mechanism of these interactions typically involves alterations in gastric pH, which can affect the solubility and absorption of various drugs.

Healthcare professionals should be aware of these interactions and consider monitoring patients for any changes in therapeutic efficacy or adverse effects when these agents are co-administered. Additionally, dosage adjustments may be necessary depending on the specific prescription drug involved and the extent of the interaction.

No further drug interactions or laboratory test interactions have been identified in the available data.

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 before use. For adolescents and adults aged 12 years and older, the recommended dosage is to chew 1 tablet before swallowing, with a maximum of 2 chewable tablets allowed within a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 safe use during pregnancy and lactation.

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 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 potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: headache, dizziness, constipation, diarrhea, and nausea. These events have been documented in the context of routine pharmacovigilance activities.

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 for 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 advised to consult a doctor 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, or pain radiating to the arms, neck, or shoulders. Frequent chest pain, wheezing (especially when associated with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain are additional symptoms that warrant a discussion with a healthcare provider prior to using this medication.

Furthermore, patients with a history of kidney disease should seek medical advice before using this product. 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 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 to relieve symptoms, with a maximum of two chewable tablets allowed 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, immediate medical assistance or contact with a Poison Control Center (1-800-222-1222) is recommended.

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)