DUO FUSION- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable 
Boehringer Ingelheim Pharmaceuticals, Inc.

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DUOFUSION™
Famotidine 10 mg/Calcium Carbonate 800 mg
Magnesium Hydroxide 165 mg Tablets
Cool Mint Flavor

Drug Facts

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

Use relieves heartburn associated with acid indigestion and sour stomach

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

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids 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)

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

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 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

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.

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

duofusion-mint-20ct-label

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

duofusion-mint-34ct-label

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

duofusion-mint-55ct-label
DUO FUSION 
famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine10 mg
Calcium Carbonate (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) Calcium Carbonate800 mg
Magnesium Hydroxide (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) Magnesium Hydroxide165 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASPARTAME (UNII: Z0H242BBR1)  
DEXTRATES (UNII: G263MI44RU)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0320-3520 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201610/29/2021
2NDC:0597-0320-7034 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201610/29/2021
3NDC:0597-0320-6955 in 1 BOTTLE; Type 0: Not a Combination Product03/01/201610/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735503/01/201610/29/2021
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
Perrigo006013346MANUFACTURE(0597-0320)

Revised: 11/2021
Document Id: 423e8aff-8b98-48d2-86b2-e1eca5995e09
Set id: 30e54e0c-2e89-ee53-0f75-8851bcbe501a
Version: 4
Effective Time: 20211101
 
Boehringer Ingelheim Pharmaceuticals, Inc.