CARE ONE ACID REDUCER AND ANTACID DUAL ACTION- famotidine, calcium carbonate, magnesium hydroxide tablet, chewable 
American Sales Company

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American Sales Company Acid Reducer + Antacid Drug Facts

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

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

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 or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredients in Pepcid Complete®

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets (Chewable)

ACID REDUCER + ANTACID

DUAL ACTION

Just One Tablet Relieves Heartburn Due to Acid Indigestion

Actual Size

Cool Mint Flavor

25 CHEWABLE TABLETS

CareOne Acid Reducer + Antacid image
CARE ONE ACID REDUCER AND ANTACID  DUAL ACTION
famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-546
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 CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE800 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, 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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorORANGE (PEACH WITH WHITE SPECKLES) Scoreno score
ShapeROUNDSize18mm
FlavorMINTImprint Code L546
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-546-6325 in 1 BOTTLE; Type 0: Not a Combination Product08/01/200806/05/2018
2NDC:41520-546-6530 in 1 BOTTLE; Type 0: Not a Combination Product08/01/200806/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07735508/01/200806/05/2018
Labeler - American Sales Company (809183973)

Revised: 10/2018
 
American Sales Company