Drugplain

Extra Strength Pain Reliever 500 mg/1

Acetaminophen · TABLET · INGLES MARKETS, INC.

3 Recalls on RecordCurrently in Shortage
Plain English

Extra Strength Pain Reliever contains 500 mg of acetaminophen and is used to temporarily relieve minor aches and pains such as headaches, muscle aches, and fever. This over-the-counter tablet is taken by mouth and works by reducing pain and fever in the body.

Key Facts

Brand Name
Extra Strength Pain Reliever
Generic Name
Acetaminophen
NDC Code (Product)
62936-0219
Manufacturer
INGLES MARKETS, INC.
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
11/01/2024

Recall History

3 Recalls on Record
Class I09/25/2015

Medline Industries Inc

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

TerminatedVoluntary: Firm initiated
Class III07/07/2021

LNK International, Inc.

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Medique Products

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use22,535 reports
fatigue20,774 reports
drug ineffective20,167 reports
pain18,331 reports
nausea18,026 reports
headache17,243 reports
toxicity to various agents15,664 reports
dyspnoea14,722 reports
arthralgia14,442 reports
pyrexia14,343 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps

Dosage & Administration

Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor

Warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non…

Frequently Asked Questions

What is Extra Strength Pain Reliever used for?

Extra Strength Pain Reliever contains 500 mg of acetaminophen and is used to temporarily relieve minor aches and pains such as headaches, muscle aches, and fever. This over-the-counter tablet is taken by mouth and works by reducing pain and fever in the body.

Is Extra Strength Pain Reliever a controlled substance?

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

What is the generic name for Extra Strength Pain Reliever?

The generic name for Extra Strength Pain Reliever is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Extra Strength Pain Reliever 500 mg/1?

The NDC (National Drug Code) for Extra Strength Pain Reliever 500 mg/1 is 62936-0219, listed by INGLES MARKETS, INC..

Product NDC

62936-0219

Package NDC

62936-0219-1

Other Acetaminophen Brands

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

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