FDA Label for Tri-buffered Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Tri-buffered Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Buffered aspirin equal to
325 mg aspirin (NSAID)*
(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
• temporarily relieves minor aches and pains associated with:• toothache• minor pain of arthritis• backache• the common cold• headache• muscular aches• premenstrual & menstrual cramps
• temporarily reduces fever
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)• have had stomach ulcers or bleeding problems• have 3 or more alcoholic drinks every day while using this product• are age 60 or older• 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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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, such as heartburn• you have asthma• you are taking a diuretic• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug for
• gout• arthritis• diabetes
Stop Use And Ask A Doctor If
• an allergic reaction occurs. Seek medical help right away.• you experience any of the following signs of stomach bleeding:• feel faint• vomit blood• have bloody or black stools• have stomach pain that does not get better
• ringing in the ears or a loss of hearing occurs• pain gets worse or lasts more than 10 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• 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
Other Information
• each tablet contains: calcium 35 mg and magnesium 40 mg• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)• see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide
Questions Or Comments?
(800) 616-2471
Principal Display Panel
NDC 71205-517-30
Compare to the active ingredient in BUFFERIN®†
TRI-BUFFERED
ASPIRIN
325 mg
pain reliever/fever reducer (NSAID)
30 TABLETS
†This product is not manufactured or distributed by Dr. Reddy's Laboratories Inc., owner of the registered trademark Bufferin®.
50844 REV0318M18312
Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Repackaged by Proficient Rx LP
Thousand Oaks, CA 91320
M-17
Re-order No. 700594 Rev. 07/18
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.