FDA Label for 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
Buffered Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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
- the common cold
- backache
- muscular aches
- headache
- minor pain of arthritis
- 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)
- are age 60 or older
- take more or for a longer time than directed
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- have 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
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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
- you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug for
- gout
- diabetes
- arthritis
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 stool
- 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 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
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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?
1-800-426-9391
Principal Display Panel
Leader™
NDC 70000-0147-1
Buffered Aspirin
Tri-Buffered Aspirin, 325 mg Tablets
Pain Reliever / Fever Reducer (NSAID)
130
COATED
TABLETS
ACTUAL SIZE
COMPARE TO
BUFFERIN®
active ingredient†
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TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
REV. 8/18
†This product is not manufactured or distributed by Dr. Reddy's
Laboratories, Inc., owner of the registered trademark Bufferin®.
50844 REV0318A18330
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
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purchase if not satisfied.
© 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health.
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