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Dual Action Complete

famotidine, calcium carbonate and magnesium hydroxide · Tablet, Chewable

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Dual Action Complete
Generic name
famotidine, calcium carbonate and magnesium hydroxide
Dosage form
Tablet, Chewable
Route
Oral
Marketing category
ANDA · ANDA
Labeler
H E B
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
8
Packages
11
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Calcium Carbonate 800 mg/1 283641 View
Famotidine 10 mg/1 283641 View
Magnesium Hydroxide 165 mg/1 283641 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Chewable
Route of administration
Oral
Presentations
19

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Calculi Dissolution Agent [EPC] EPC All 33 members
Histamine H2 Receptor Antagonists [MoA] MoA All 48 members
Histamine-2 Receptor Antagonist [EPC] EPC All 48 members
Increased Large Intestinal Motility [PE] PE All 83 members
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] PE All 83 members
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] PE All 30 members
Magnesium Ion Exchange Activity [MoA] MoA All 30 members
Osmotic Activity [MoA] MoA All 105 members
Osmotic Laxative [EPC] EPC All 103 members
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] PE All 53 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
077355
Application type
ANDA · Abbreviated New Drug Application
Approval date
February 6, 2008
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
1
Products approved under application 077355.
Product Trade name Form Strength Ingredient Status TE Flags
077355-001 FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLE CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077355.
Type No. Action Status Date Review
Original application 1 Approved February 6, 2008 —

Review documents

  • 0 · Original application · March 20, 2008

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250814). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250814 HUMAN OTC DRUG · 20250707

Indications and Usage

openFDA Drug Labeling

Use relieves heartburn associated with acid indigestion and sour stomach

Purpose

openFDA Drug Labeling

Purposes Acid reducer Antacid

Dosage and Administration

openFDA Drug Labeling

Directions • adults and children 12 years and over: • do not swallow tablet whole: chew completely • to relieve symptoms, chew 1 tablet before swallowing • do not use more than 2 chewable tablets in 24 hours • children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy alert : Do not use if you are allergic to famotidine or other acid reducers Do not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. • with other acid reducers Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with lightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do Not Use

openFDA Drug Labeling

Do not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. • with other acid reducers

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with lightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • kidney disease

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each chewable tablet) Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg

Adverse event reports

Source: openFDA FAERS
118,947
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FAMOTIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72288-774-71 72288-774 Amazon.com Services LLC 50 TABLET, CHEWABLE in 1 BOTTLE (72288-774-71) July 16, 2026
37808-121-63 37808-121 H E B 25 TABLET, CHEWABLE in 1 BOTTLE (37808-121-63) April 7, 2016
37808-503-63 37808-503 H E B 25 TABLET, CHEWABLE in 1 BOTTLE (37808-503-63) April 7, 2016
37808-503-71 37808-503 H E B 50 TABLET, CHEWABLE in 1 BOTTLE (37808-503-71) June 10, 2021
30142-040-63 30142-040 Kroger Company 25 TABLET, CHEWABLE in 1 BOTTLE (30142-040-63) February 1, 2016
30142-040-71 30142-040 Kroger Company 50 TABLET, CHEWABLE in 1 BOTTLE (30142-040-71) February 1, 2016
30142-213-71 30142-213 Kroger Company 50 TABLET, CHEWABLE in 1 BOTTLE (30142-213-71) February 3, 2016
41250-284-71 41250-284 Meijer Distribution Inc 50 TABLET, CHEWABLE in 1 BOTTLE (41250-284-71) January 26, 2016
41250-690-71 41250-690 Meijer Distribution Inc 50 TABLET, CHEWABLE in 1 BOTTLE (41250-690-71) January 26, 2016
56062-263-63 56062-263 Publix Super Markets Inc 25 TABLET, CHEWABLE in 1 BOTTLE (56062-263-63) November 6, 2018
56062-263-71 56062-263 Publix Super Markets Inc 50 TABLET, CHEWABLE in 1 BOTTLE (56062-263-71) November 6, 2018
72288-774 72288-774 Amazon.com Services LLC — July 16, 2026
37808-121 37808-121 H E B — April 7, 2016
37808-503 37808-503 H E B — April 7, 2016
30142-040 30142-040 Kroger Company — February 1, 2016
30142-213 30142-213 Kroger Company — February 3, 2016
41250-284 41250-284 Meijer Distribution Inc — January 26, 2016
41250-690 41250-690 Meijer Distribution Inc — January 26, 2016
56062-263 56062-263 Publix Super Markets Inc — November 6, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.