ASCRIPTIN REGULAR STRENGTH BUFFERED ASPIRIN
tablet, film coated
[Novartis Consumer Health, Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Active ingredient(in each tablet)
Buffered aspirin equal to 325 mg aspirin (NSAID)*
(buffered with aluminum hydroxide, calcium carbonate, and magnesium hydroxide)
*nonsteroidal anti-inflammatory drug
- for the temporary relief of minor aches and pains associated with:
- muscular aches
- premenstrual & menstrual cramps
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
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if you have
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretic
- reached age 60 or older
Ask a doctor or pharmacist before use if you are taking:
- any other drug containing an NSAID (prescription or nonprescription)
- a blood thinning (anticoagulant) or steroid drug
- a prescription drug for diabetes, gout, or arthritis
- any other drug, or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
- stomach pain or upset gets worse or lasts
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear
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.
- do not use 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 while symptoms persist; not more than 12 tablets in 24 hours
- children under 12 years: ask a doctor
- each tablet contains: calcium 70 mg, and magnesium 10 mg
- store at controlled room temperature 200 - 250 C (680 - 770 F)
- protect from moisture and excessive heat
Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, granular sugar, hypromellose, magnesium stearate, mannitol, methylparaben, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, sodium saccharin, sorbitol, talc, titanium dioxide
Questions or comments?
Novartis Consumer Health, Inc.
200 Kimball Drive
Parsippany, NJ 07054-0622
REGULAR STRENGTH BUFFERED ASPIRIN
aspirin tablet, film coated
|Labeler - Novartis Consumer Health, Inc. (879821635)|