Pepcid Complete

Description

No description information is available for the drug.

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 older 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 use.

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 product 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.

Caution is advised for patients who have experienced heartburn for more than three months, as this may signal a more serious health issue. Additionally, individuals 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 prior to use.

Patients taking prescription medications should consult with their 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 contact a Poison Control Center 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 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 the presence of bloody or black stools, as these symptoms may indicate a serious underlying condition that requires medical attention.

Before initiating treatment, patients should 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 are advised to 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. These precautions are essential to ensure patient safety and to address any potential serious conditions that may arise during treatment.

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 specific drug interactions or laboratory test interactions have been identified in the available data. Therefore, ongoing assessment and clinical judgment are recommended when prescribing medications alongside antacids or acid reducers.

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

Children under 12 years should consult a healthcare professional before use. For adults and children aged 12 years and older, the recommended dosage is to chew 1 tablet before swallowing, with a maximum of 2 chewable tablets in a 24-hour period. It is important to keep this medication 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

Elderly patients should consult a healthcare provider prior to using this medication if they have a history of kidney disease. This precaution is particularly important as renal function may be compromised in geriatric populations, potentially affecting the pharmacokinetics and safety profile of the medication. Careful monitoring and consideration of dosage adjustments may be necessary to mitigate the risk of adverse effects in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its 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 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. 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 attention can significantly influence outcomes. 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 of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should be prepared to implement appropriate interventions based on the clinical presentation and the specific substance involved. Continuous monitoring of vital signs and supportive measures may be necessary until the patient stabilizes.

In summary, immediate action and professional guidance are critical in the event of an overdose to ensure the safety and well-being of the affected individual.

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

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 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 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, 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.

Patients should be encouraged to discuss any frequent chest pain, wheezing (especially in conjunction with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain with their healthcare provider prior to using this medication. Furthermore, patients with a history of kidney disease should consult their doctor before use.

Lastly, healthcare providers should remind patients to speak with their 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 controlled room temperature of 20° to 25°C (68° to 77°F). Care must be taken to protect the product from moisture to ensure its integrity. Additionally, the product should not be used if the foil inner seal, which is imprinted with "Sealed For Your Safety," is broken or missing, as this may compromise the safety and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential 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 further 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)