Aspirin by KEM Pharma LLC
Dosage form: tablet, coated
Ingredients: ASPIRIN 325mg
Labeler: KEM Pharma LLC
NDC Code: 60503-227
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever
- for the temporary relief of minor aches and pains due to:
- colds
- toothache
- menstrual pain
- headache
- muscle pain
- minor pain of arthritis
- or as recommended by a doctor
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:
- shock
- facial swelling
- hives
- 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
- take more or for a longer time than directed
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
if you are allergic to aspirin or any other pain reliever/fever reducer.
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
taking a prescription drug for
- gout
- diabetes
- arthritis
- 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
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- ringing in the ears or 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
These could be signs of a serious condition.
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last
- do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Enteric
Aspirin 325 mg
Pain Reliever (NSAID)
Enteric Coated Orange Tablets
Actual Size
Safety Coated
Aspirin Regimen
Regular Strength
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CLOSE TIGHTLY
TO OPEN PUSH DOWN AND TURN
This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Ecotrin®.
50844 ORG111322712
Kem Pharma 44-227
| ASPIRIN
aspirin tablet, coated |
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| Labeler - KEM Pharma LLC (079090402) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 038154464 | PACK(60503-227) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(60503-227) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 868734088 | MANUFACTURE(60503-227), PACK(60503-227) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| LNK International, Inc. | 967626305 | PACK(60503-227) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.
