Drugplain

CareOne Acid Reducer Complete 800 mg/1

Famotidine, Calcium Carbonate, Magnesium Hydroxide · TABLET, CHEWABLE · American Sales Company

No Recall History
Plain English

Careone Acid Reducer Complete is an over-the-counter chewable tablet that combines famotidine (a histamine-2 receptor antagonist that reduces stomach acid) with antacids to relieve heartburn, acid indigestion, and upset stomach. This combination product works both to decrease acid production and neutralize existing stomach acid for faster relief.

Key Facts

Brand Name
CareOne Acid Reducer Complete
Generic Name
Famotidine, Calcium Carbonate, Magnesium Hydroxide
NDC Code (Product)
41520-617
Manufacturer
American Sales Company
Strength
800 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
ANDA077355
Drug Class
Histamine-2 Receptor Antagonist [EPC]
Marketing Start
10/04/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective80 reports
chronic kidney disease51 reports
drug effect less than expected34 reports
renal failure27 reports
acute kidney injury23 reports
off label use21 reports
end stage renal disease14 reports
expired product administered14 reports
gastrooesophageal reflux disease14 reports
wrong technique in product usage process14 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use relieves heartburn associated with acid indigestion and sour stomach

Dosage & Administration

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

Warnings

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. (1-800-22…

Frequently Asked Questions

What is CareOne Acid Reducer Complete used for?

Careone Acid Reducer Complete is an over-the-counter chewable tablet that combines famotidine (a histamine-2 receptor antagonist that reduces stomach acid) with antacids to relieve heartburn, acid indigestion, and upset stomach. This combination product works both to decrease acid production and neutralize existing stomach acid for faster relief.

Is CareOne Acid Reducer Complete a controlled substance?

CareOne Acid Reducer Complete is not classified as a controlled substance by the DEA.

What is the generic name for CareOne Acid Reducer Complete?

The generic name for CareOne Acid Reducer Complete is Famotidine, Calcium Carbonate, Magnesium Hydroxide. There are 11 other brand versions of Famotidine, Calcium Carbonate, Magnesium Hydroxide.

What is the NDC code for CareOne Acid Reducer Complete 800 mg/1?

The NDC (National Drug Code) for CareOne Acid Reducer Complete 800 mg/1 is 41520-617, listed by American Sales Company.

Product NDC

41520-617

Package NDC

41520-617-63

Other Famotidine, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)