Drugplain

acid controller 20 mg/1

famotidine · TABLET, FILM COATED · Walgreen Company

3 Recalls on Record
Plain English

acid controller is a tablet, film coated containing famotidine at 20 mg/1, taken oral. Manufactured by Walgreen Company.

Key Facts

Brand Name
acid controller
Generic Name
famotidine
NDC Code (Product)
0363-1203
Manufacturer
Walgreen Company
Strength
20 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA077351
Drug Class
Histamine-2 Receptor Antagonist [EPC]
Marketing Start
04/07/2022

Recall History

3 Recalls on Record
Class III10/03/2017

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.

TerminatedVoluntary: Firm initiated
Class II05/12/2015

Allegiant Health

CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class III04/22/2016

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea5,131 reports
fatigue4,910 reports
diarrhoea4,649 reports
chronic kidney disease4,008 reports
off label use3,980 reports
dyspnoea3,779 reports
drug ineffective3,768 reports
headache3,379 reports
vomiting3,197 reports
pain3,072 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Dosage & Administration

Directions • adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn • do not use more than 2 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. 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)

Frequently Asked Questions

What is acid controller used for?

acid controller contains famotidine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is acid controller a controlled substance?

acid controller is not classified as a controlled substance by the DEA.

What is the generic name for acid controller?

The generic name for acid controller is famotidine. There are 11 other brand versions of famotidine.

What is the NDC code for acid controller 20 mg/1?

The NDC (National Drug Code) for acid controller 20 mg/1 is 0363-1203, listed by Walgreen Company.