Dual Action Pepcid Complete

Description

Pepcid Complete is a chewable tablet formulation that combines two active antacid ingredients, calcium carbonate (800 mg) and magnesium hydroxide (165 mg), with famotidine (10 mg), an acid reducer. This dual-action product is indicated for the relief of heartburn associated with acid indigestion. The tablets are presented in a berry flavor and are packaged with a count of two tablets per carton.

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 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

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if heartburn persists or worsens. Additionally, if the product is required for more than 14 days, medical advice should be sought.

Warnings and Precautions

Use of this medication is contraindicated in individuals with a known allergy to famotidine or other acid-reducing agents. It is imperative that patients refrain from using this medication if they experience difficulty or pain while swallowing, 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 health issue. Additional symptoms that warrant medical consultation include heartburn accompanied by lightheadedness, sweating, or dizziness; chest or shoulder pain associated with shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; recurrent wheezing, particularly in conjunction with heartburn; unexplained weight loss; nausea or vomiting; stomach pain; or a history of kidney disease.

It is also essential to inform patients to seek guidance from a healthcare provider or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids and acid reducers may interact with certain medications.

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 should 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.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. Serious conditions may arise, and it is crucial to discontinue use and consult a healthcare professional if any of the following symptoms occur: difficulty or pain when swallowing food, vomiting that includes blood, or the presence of bloody or black stools, as these may indicate a serious underlying condition.

Patients are advised to seek medical advice before 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 or shoulder pain accompanied by shortness of breath, sweating, or pain radiating to the arms, neck, or shoulders; frequent chest pain; and frequent wheezing, particularly in conjunction with heartburn. Unexplained weight loss, nausea or vomiting, stomach pain, and a history of kidney disease are also important considerations that should prompt a discussion with a healthcare provider prior to use.

Patients should stop using the medication 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. Additionally, individuals with known allergies to famotidine or other acid reducers should avoid using this medication.

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. This precaution is particularly important for drugs that have a narrow therapeutic index or are significantly affected by changes in gastric pH. Regular monitoring of therapeutic outcomes may be warranted to ensure optimal efficacy of the prescribed medications.

Packaging & NDC

Below are the non-prescription pack sizes of Dual Action Pepcid Complete (famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable). 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 should not be swallowed whole; it must be chewed completely 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 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to mitigate any adverse effects associated with the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Commonly reported adverse reactions include headache, dizziness, constipation, diarrhea, and nausea.

Additionally, there have been reports of allergic reactions, such as rash, pruritus, and angioedema. Rare cases of hepatic dysfunction have been documented, characterized by elevated liver enzymes and jaundice.

Cardiovascular events, including arrhythmias and palpitations, have also been reported. Furthermore, instances of renal impairment, such as acute interstitial nephritis, have been noted.

Lastly, cases of confusion and hallucinations have been observed, particularly among elderly patients or those with renal impairment.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be instructed to discontinue use and consult a doctor if their heartburn persists or worsens. It is important to inform patients that they should not use this product for more than 14 days without consulting a healthcare professional.

Patients should be encouraged to discuss their symptoms with a doctor if they have experienced heartburn for over three months, as this may indicate a more serious underlying condition. Additionally, healthcare providers should emphasize the importance of seeking medical advice if patients experience heartburn accompanied by lightheadedness, sweating, or dizziness.

Patients should also be advised to consult a doctor 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, wheezing (especially when associated with heartburn), unexplained weight loss, nausea, vomiting, or stomach pain are other symptoms that warrant a discussion with a healthcare provider prior to using the product.

Furthermore, patients with a history of kidney disease should be advised to consult a doctor before use. It is also crucial for patients to inform their healthcare provider or pharmacist if they are 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, consultation with a doctor is advised 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 should consult a doctor or pharmacist if they are taking prescription medications, as antacids and acid reducers may interact with certain drugs. Pregnant or breastfeeding patients are also encouraged to consult a health professional before use.

Drug Information (PDF)

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

View product document (PDF)