DUO FUSION- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

DUO Fusion by

Drug Labeling and Warnings

DUO Fusion by is a Otc medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals, Inc., Perrigo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

• Active ingredients(in each chewable tablet): Purpose
• Famotidine 10 mg: Acid Reducer
• Calcium carbonate 800 mg: Antacid
• Magnesium hydroxide 165 mg: Antacid

DOSAGE FORMS & STRENGTHS

DOSAGE & ADMINISTRATION

WHEN USING

Use relieves heartburn associated with acid indigestion and sour stomach

WARNINGS

Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

PURPOSE

CLINICAL PHARMACOLOGY

DO NOT USE

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 DOCTOR

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

QUESTIONS

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

STOP USE

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

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

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

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

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

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.

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

DUO FUSION 
famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0320
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8)	Famotidine	10 mg
Calcium Carbonate (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D)	Calcium Carbonate	800 mg
Magnesium Hydroxide (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P)	Magnesium Hydroxide	165 mg

Inactive Ingredients
Ingredient Name	Strength
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)
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0320-35	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016
2	NDC: 0597-0320-70	34 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016
3	NDC: 0597-0320-69	55 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077355	03/01/2016

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Establishment
Name	Address	ID/FEI	Business Operations
Perrigo		006013346	MANUFACTURE(0597-0320)