TOPCARE COMPLETE- famotidine, calcium carbonate and magnesium hydroxide tablet, chewable 
Topco Associates LLC

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Topco Associates LLC. Complete Drug Facts

Active ingredient (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Uses

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 320 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, 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

DUAL ACTION

Complete

Famotidine 10 mg/ Calcium Carbonate 800 mg

Magnesium Hydroxide 165 mg Tablets

Acid Reducer plus Antacid

Just one tablet

Relieves heartburn due to acid indigestion

Berry Flavor

actual size

COMPARE TO PEPCID COMPLETE® active ingredients

Complete Label Image 1

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TOPCARE COMPLETE 
famotidine, calcium carbonate and magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-321
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) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
DEXTRATES (UNII: G263MI44RU)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINK (mottled) Scoreno score
ShapeROUND (bi-layered) Size17mm
FlavorBERRYImprint Code L321
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-321-6325 in 1 BOTTLE; Type 0: Not a Combination Product08/05/200805/01/2017
2NDC:36800-321-7150 in 1 BOTTLE; Type 0: Not a Combination Product08/05/200805/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735508/05/200805/01/2017
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
Document Id: ca9aba1b-a6e2-49db-a577-75cf954d336b
Set id: 9f8eb044-f482-46b7-a5f1-f4a17e15d647
Version: 3
Effective Time: 20171109
 
Topco Associates LLC