Drugplain

Extra Strength 750 mg/1

Antacid Tablets · TABLET, CHEWABLE · SAFEWAY

10 Recalls on Record
Plain English

Extra Strength is a tablet, chewable containing antacid tablets at 750 mg/1, taken oral. Manufactured by SAFEWAY.

Key Facts

Brand Name
Extra Strength
Generic Name
Antacid Tablets
NDC Code (Product)
21130-207
Manufacturer
SAFEWAY
Strength
750 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M001
Marketing Start
10/05/2020

Recall History

10 Recalls on Record
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II02/03/2020

Contract Pharmacal Corporation

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

TerminatedVoluntary: Firm initiated
Class I12/12/2025

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

OngoingVoluntary: Firm initiated
Class I03/02/2021

A-S Medication Solutions LLC.

Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.

TerminatedVoluntary: Firm initiated
Class II11/03/2017

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II05/07/2018

RIJ Pharmaceutical LLC

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

TerminatedVoluntary: Firm initiated
Class III07/18/2024

Granules Consumer Health Inc.

Label mix-up: Carton incorrectly labeled.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue69,079 reports
drug ineffective67,156 reports
nausea60,613 reports
off label use56,633 reports
dyspnoea53,553 reports
diarrhoea52,628 reports
headache50,897 reports
pain48,161 reports
dizziness41,271 reports
vomiting40,213 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. 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 cont

Frequently Asked Questions

What is Extra Strength used for?

Extra Strength contains Antacid Tablets. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Extra Strength a controlled substance?

Extra Strength is not classified as a controlled substance by the DEA.

What is the generic name for Extra Strength?

The generic name for Extra Strength is Antacid Tablets. There are 10 other brand versions of Antacid Tablets.

What is the NDC code for Extra Strength 750 mg/1?

The NDC (National Drug Code) for Extra Strength 750 mg/1 is 21130-207, listed by SAFEWAY.