ASPIRIN 325 MG EC TABLET
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Aspirin USP, 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Pain Reliever/Fever Reducer
INDICATIONS & USAGE SECTION
temporarily relieves
- headache
- menstrual pain
- minor pain of arthritis
- muscle pain
- toothache
- pain and fever of colds
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 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.
OTHER SAFETY INFORMATION
Allergy alert: Aspirin may cause a severe allergic reaction which may include
- hives
- facial swelling
- asthma (wheezing)
- shock
OTHER SAFETY INFORMATION
Stomach bleeding warning: This prodcut contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Drug Facts continued on back of label
- 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
OTC - DO NOT USE SECTION
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor if
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
These could be sings of a serious condition
- you experience any of the following signs of stomach bleeding:
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
- children under 12 years: ask a doctor
Other information
- store at room temperature 15°-30ºC (59°-86°F)
Inactive ingredients
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
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
SPL UNCLASSIFIED SECTION
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
www.reliable1labs.com
HOW SUPPLIED
NDC: 71335-1800-1: 30 Tablets in a BOTTLE
NDC: 71335-1800-2: 60 Tablets in a BOTTLE
NDC: 71335-1800-3: 100 Tablets in a BOTTLE
NDC: 71335-1800-4: 90 Tablets in a BOTTLE
NDC: 71335-1800-5: 20 Tablets in a BOTTLE
NDC: 71335-1800-6: 45 Tablets in a BOTTLE
NDC: 71335-1800-7: 120 Tablets in a BOTTLE
NDC: 71335-1800-8: 7 Tablets in a BOTTLE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Aspirin E.C 325mg Tablet