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, 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

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: 0597-0315-97

PRINCIPAL DISPLAY PANEL

DUO Fusion™ 34 ct Label
NDC: 0597-0315-36

PRINCIPAL DISPLAY PANEL

DUO Fusion™ 55 ct Label
NDC: 0597-0315-08

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0597-0315
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
DEXTRATES (UNII: G263MI44RU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
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	PURPLE	Score	no score
Shape	ROUND	Size	17mm
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0597-0315-97	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016
2	NDC: 0597-0315-36	34 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016
3	NDC: 0597-0315-08	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	PACK(0597-0315) , MANUFACTURE(0597-0315)