Over-the-counter medicine
Calcium carbonate and famotidine and magnesium hydroxide Brand names: Pepcid, Dual; first approved as Pepcid Complete
Calcium carbonate and famotidine and magnesium hydroxide (Pepcid) is an over-the-counter medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.258 per tablet (Acid reducer complete tablet chewable) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the calcium carbonate and famotidine and magnesium hydroxide FDA label on DailyMed (effective July 24, 2026, Kenvue Brands LLC); the NDA 20958 record on Drugs@FDA; every calcium carbonate and famotidine and magnesium hydroxide label on DailyMed.
Highlights of the record
FDA label of July 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagerelieves heartburn associated with acid indigestion and sour stomach
Forms and strengths
- 10 mg / 800 mg / 165 mg
- 10 mg / 165 mg / 800 mg
- 165 mg / 10 mg / 800 mg
Chewable tablet; tablet.
On the market
- Earliest approval on file
- October 16, 2000 Pepcid Complete, Kenvue Brands; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first February 6, 2008; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 20 under generic applications, 8 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.258 per tablet Acid reducer complete tablet chewable
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,415 through July 30, 2026
What is calcium carbonate and famotidine and magnesium hydroxide used for?
From the label: indications and usagerelieves heartburn associated with acid indigestion and sour stomach
Conditions named in the indications of calcium carbonate and famotidine and magnesium hydroxide's FDA labels, with every medicine labeled for each:
From other calcium carbonate and famotidine and magnesium hydroxide labelsAcid reflux and ulcers: Use relieves heartburn associated with acid indigestion and sour stomach
FDA pharmacologic class: Blood Coagulation Factor, Calculi Dissolution Agent, Histamine-2 Receptor Antagonist, Osmotic Laxative and Phosphate Binder.
Source: FDA drug label (Pepcid Complete), Kenvue Brands LLC, effective July 24, 2026 (SPL set a2ef8424-7d80-42b0-a01e-f378f629b2b6), via openFDA; the full label on DailyMed
Is there a generic for calcium carbonate and famotidine and magnesium hydroxide (Pepcid)?
The FDA approved the first generic calcium carbonate and famotidine and magnesium hydroxide on February 6, 2008. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists calcium carbonate and famotidine and magnesium hydroxide from 20 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2008 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for calcium carbonate and famotidine and magnesium hydroxide (Pepcid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.258 per tablet (Acid reducer complete tablet chewable), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Acid reducer complete tablet chewable (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acid reducer complete tablet chewable | Generic | $0.258 per tablet | $7.73 | -0.7% |
| Ft acid reducer-antacid tablet chw | Generic | $0.258 per tablet | $7.73 | -0.7% |
| Gnp dual actn complete tablet chewable | Generic | $0.258 per tablet | $7.73 | n/a |
| Gs dual action complete tablet chw | Generic | $0.258 per tablet | $7.73 | -0.7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for calcium carbonate and famotidine and magnesium hydroxide?
The FDA Adverse Event Reporting System holds 2,415 reports that list calcium carbonate and famotidine and magnesium hydroxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 77 are coded as a death and 132 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as calcium carbonate and famotidine and magnesium hydroxide?
19 other medicines are given the same way (oral) and in the same FDA class as calcium carbonate and famotidine and magnesium hydroxide or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sodium bicarbonate | Acid reflux and ulcers | none listed | $0.0128 per tablet 650 mg tablet | In shortage |
| Cimetidine | Acid reflux and ulcers | 18 labelers | $0.236 per tablet 300 mg tablet | No current entry |
| Omeprazole and sodium bicarbonate | Acid reflux and ulcers | 20 labelers | $7.90 per packet 40-1,680 packet | No current entry |
| Ranitidine | Acid reflux and ulcers | 8 labelers | n/a | No current entry |
| Trisodium citrate | Acid reflux and ulcers | none listed | n/a | No current entry |
| Nizatidine | Acid reflux and ulcers | 4 labelers | $0.804 per capsule 150 mg capsule | No current entry |
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to calcium carbonate and famotidine and magnesium hydroxide
- 19 medicines for the same use
- Other blood coagulation factors
- the pharmacologic class, with prices and generics
- Calcium carbonate and famotidine and magnesium hydroxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other