Drugplain

Extra Strength Aspirin 325 mg/1

Aspirin · TABLET, FILM COATED · HHH Pharmaceuticals

1 Recall on Record
Plain English

Extra Strength Aspirin is a tablet, film coated containing aspirin at 325 mg/1, taken oral. Manufactured by HHH Pharmaceuticals.

Key Facts

Brand Name
Extra Strength Aspirin
Generic Name
Aspirin
NDC Code (Product)
83586-115
Manufacturer
HHH Pharmaceuticals
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
07/28/2025

Recall History

1 Recall on Record
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

Side Effects Reported to FDA

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

fatigue48,849 reports
nausea41,125 reports
dyspnoea39,192 reports
off label use38,570 reports
drug ineffective37,416 reports
diarrhoea37,030 reports
headache33,605 reports
pain33,379 reports
dizziness30,098 reports
vomiting27,980 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years of age and over: • take 1 to 2 tablets every 4 hours while symptoms last • do not take more than 12 tablets in 24 hours unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children under 12 years: do not use unless directed by 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: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling asthma (wheezing) shock 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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, live

Frequently Asked Questions

What is Extra Strength Aspirin used for?

Extra Strength Aspirin contains Aspirin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Extra Strength Aspirin a controlled substance?

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

What is the generic name for Extra Strength Aspirin?

The generic name for Extra Strength Aspirin is Aspirin. There are 12 other brand versions of Aspirin.

What is the NDC code for Extra Strength Aspirin 325 mg/1?

The NDC (National Drug Code) for Extra Strength Aspirin 325 mg/1 is 83586-115, listed by HHH Pharmaceuticals.