FDA.reportPublic FDA data

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 01:23:03

Label at a glance#

ProductDUO Fusion
Active ingredientFamotidine, Calcium Carbonate, Magnesium Hydroxide
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients
(in each chewable tablet)		Purpose
Famotidine 10 mgAcid Reducer
Calcium carbonate 800 mgAntacid
Magnesium hydroxide 165 mgAntacid

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

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

OTC - ASK DOCTOR SECTION

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

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

Stop use and ask a doctor if
  • 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, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, 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

DUO Fusion™ 20 ct Label
NDC: 0597-0320-35

duofusion-mint-20ct-label
duofusion-mint-20ct-label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUO Fusion™ 34 ct Label
NDC: 0597-0320-70

duofusion-mint-34ct-label
duofusion-mint-34ct-label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DUO Fusion™ 55 ct Label
NDC: 0597-0320-69

duofusion-mint-55ct-label
duofusion-mint-55ct-label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0597-0320-352021-11-08C16284748780-19d75b9d0-4c8a-f424-e053-dadaa90a57ceDUOFUSION™ Famotidine 10 mg/Calcium Carbonate 800 mg Magnesium Hydroxide 165 mg Tablets Cool Mint Flavor
0597-0320-692021-11-08C16284748780-19d75b9d0-4c8a-f424-e053-dadaa90a57ceDUOFUSION™ Famotidine 10 mg/Calcium Carbonate 800 mg Magnesium Hydroxide 165 mg Tablets Cool Mint Flavor
0597-0320-702021-11-08C16284748780-19d75b9d0-4c8a-f424-e053-dadaa90a57ceDUOFUSION™ Famotidine 10 mg/Calcium Carbonate 800 mg Magnesium Hydroxide 165 mg Tablets Cool Mint Flavor
0597-0320-352020-01-31C16284748780-19d75b9d0-4c8a-f424-e053-dadaa90a57ceDUOFUSION™ Famotidine 10 mg/Calcium Carbonate 800 mg Magnesium Hydroxide 165 mg Tablets Cool Mint Flavor
0597-0320-692020-01-31C16284748780-19d75b9d0-4c8a-f424-e053-dadaa90a57ceDUOFUSION™ Famotidine 10 mg/Calcium Carbonate 800 mg Magnesium Hydroxide 165 mg Tablets Cool Mint Flavor
0597-0320-702020-01-31C16284748780-19d75b9d0-4c8a-f424-e053-dadaa90a57ceDUOFUSION™ Famotidine 10 mg/Calcium Carbonate 800 mg Magnesium Hydroxide 165 mg Tablets Cool Mint Flavor

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0597-03200597-0320-35, 0597-0320-70, 0597-0320-69

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Famotidine5QZO15J2Z8ACTIB
Calcium CarbonateH0G9379FGKACTIB
Magnesium HydroxideNBZ3QY004SACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
ASPARTAMEZ0H242BBR1IACT
DEXTRATESG263MI44RUIACT
FERRIC OXIDE RED1K09F3G675IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONESFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDECALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063f01610625f2…
2019-09-15 20:21 UTC2019-09A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077355-001FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE800MG;10MG;165MGTABLET, CHEWABLE / ORAL2008-02-06f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
423e8aff-8b98-48d2-86b2-e1eca5995e0930e54e0c-2e89-ee53-0f75-8851bcbe501a2021-11-01WarningsExact identifier
spl set id: 30e54e0c-2e89-ee53-0f75-8851bcbe501a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.