TOPCARE DUAL ACTION COMPLETE- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

topcare dual action complete by

Drug Labeling and Warnings

topcare dual action complete by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purposes

Acid reducer

Antacid

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
• kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids and acid reducers 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 80 mg
• Phenylketonurics: Contains Phenylalanine 2 mg per tablet
• read the directions and warnings before use
• read the bottle. It contains important information.
• store at 20-25°C (68-77°F)
• protect from moisture

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, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO PEPCID COMPLETE® ACTIVE INGREDIENTS

Dual Action Complete

SEE NEW WARNINGS

FAOTIDINE 10 mg, CALCIUM CARBONATE 800 mg

MAGNESIUM HYDROXIDE 165 mg TABLETS (CHEWABLE)

ACID REDUCER + ANTACID

Just One Tablet Relieves Heartburn Due to Acid Indigestion

actual size

25 CHEWABLE TABLETS

BERRY FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE DUAL ACTION COMPLETE 
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-616
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 CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, 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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK (mottled)	Score	no score
Shape	ROUND (bi-layered)	Size	17mm
Flavor	BERRY	Imprint Code	L321
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-616-63	25 in 1 BOTTLE; Type 0: Not a Combination Product	02/29/2016
2	NDC: 36800-616-71	50 in 1 BOTTLE; Type 0: Not a Combination Product	02/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077355	02/29/2016

Labeler - Topco Associates LLC (006935977)