DUO Fusion
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc. | Perrigo
- Effective date
- 2016-09-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:23:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
| Active ingredients (in each chewable tablet) | Purpose |
| Famotidine 10 mg | Acid Reducer |
| Calcium carbonate 800 mg | Antacid |
| Magnesium hydroxide 165 mg | Antacid |
OTC - WHEN USING SECTION
Use relieves heartburn associated with acid indigestion and sour stomach
WARNINGS SECTION
Warnings
Allergy alert: Do
not use if you are allergic to famotidine or other acid reducers
OTC - DO NOT USE SECTION
- 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
OTC - ASK DOCTOR SECTION
- 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
OTC - QUESTIONS SECTION
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
OTC - STOP USE SECTION
- your heartburn continues or worsens
- you need to take this product for more than 14 days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)
INDICATIONS & USAGE SECTION
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
HOW SUPPLIED SECTION
Other information
- each tablet contains: calcium 330 mg; magnesium 70 mg
- Phenylketonurics: Contains phenylalanine 2.2 mg per tablet
- read the directions and warnings before use
- read the bottle label. It contains important information.
- store at 20-25°C (68-77°F)
- protect from moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glycerol monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc
INFORMATION FOR PATIENTS SECTION
Questions? Call 1-888-285-9159 (English/Spanish)
M – F, 8:30 – 5 EST, or visit
www.DuoFusion.com
Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. © 2016, BI Pharmaceuticals, Inc. All rights reserved.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
Products#
Every source-derived product name is available through these pages.
- DUO Fusion
- Famotidine, Calcium carbonate, Magnesium hydroxide
- Famotidine
- Calcium Carbonate
- CARBONATE ION
- Magnesium Hydroxide
- Hydroxide ION
- ANHYDROUS LACTOSE
- ASPARTAME
- D&C RED NO. 7
- DEXTRATES
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- ALUMINUM OXIDE
- GLYCERYL MONOSTEARATE
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- POLYSORBATE 80
- POVIDONES
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0597-0315 | 0597-0315-97, 0597-0315-36, 0597-0315-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077355-001 | FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 800MG;10MG;165MG | TABLET, CHEWABLE / ORAL | 2008-02-06 | f41ea6bd6efb… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2ab8f2e5-e48a-495e-9094-e8953e3988cb | 10abaed0-f345-c4e6-70eb-83ae32bf3d8a | 2021-11-01 | Warnings | 10abaed0-f345-c4e6-70eb-83ae32bf3d8a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


