ASPIRIN 325 MG EC: Package Insert and Label Information
ASPIRIN 325 MG EC- aspirin tablet
NuCare Pharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Aspirin USP, 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain Reliever/Fever Reducer
- menstrual pain
- minor pain of arthritis
- muscle pain
- pain and fever of colds
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 prodcut, 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 prodcut 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 (ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Drug Facts continued on back of label
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
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 are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
- under a doctor’s care for any serious condition
- taking any other drug
Stop use and ask a doctor if
- 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasta more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
These could be sings of a serious condition
If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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.
DRINK A FULL GLASS OF WATER WITH EACH DOSE
- adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
- children under 12 years: ask a doctor
- store at room temperature 15°-30ºC (59°-86°F)
croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide
Questions or comments?
Questions or comments ? call 516-341-0666, 8:30 am — 4:30 pm ET, Monday — Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
| ASPIRIN 325 MG EC |
|Labeler — NuCare Pharmaceuticals, Inc. (010632300)|
|NuCare Pharmaceuticals, Inc.||010632300||repack (68071-3189)|
Revised: 02/2021 NuCare Pharmaceuticals, Inc.
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