Drugplain

Tri-Buffered Aspirin 325 mg/1

Aspirin · TABLET, FILM COATED · Proficient Rx LP

1 Recall on Record
Plain English

Tri-Buffered Aspirin is a prescription tablet, film coated containing aspirin at 325 mg/1, taken oral. Manufactured by Proficient Rx LP.

Key Facts

Brand Name
Tri-Buffered Aspirin
Generic Name
Aspirin
NDC Code (Product)
71205-517
Manufacturer
Proficient Rx LP
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M013
Drug Class
Anti-Inflammatory Agents; Non-Steroidal [CS]
Marketing Start
03/30/1990

Recall History

1 Recall on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: W003596, EXP: 5/31/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue31,120 reports
dyspnoea26,620 reports
nausea25,845 reports
diarrhoea25,653 reports
dizziness21,841 reports
drug ineffective20,811 reports
headache19,014 reports
asthenia18,356 reports
off label use18,134 reports
fall18,117 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours 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 shock asthma (wheezing) 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 have 3 or more alcoholic drinks every day while using this product take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 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 if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems,

Frequently Asked Questions

What is Tri-Buffered Aspirin used for?

Tri-Buffered Aspirin contains Aspirin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Tri-Buffered Aspirin a controlled substance?

Tri-Buffered Aspirin is not classified as a controlled substance by the DEA.

What is the generic name for Tri-Buffered Aspirin?

The generic name for Tri-Buffered Aspirin is Aspirin. There are 12 other brand versions of Aspirin.

What is the NDC code for Tri-Buffered Aspirin 325 mg/1?

The NDC (National Drug Code) for Tri-Buffered Aspirin 325 mg/1 is 71205-517, listed by Proficient Rx LP.