ADULT LOW DOSE- aspirin 81 mg tablet, delayed release
Safrel Pharmaceuticals, LLC.
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.
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Active Ingredients (in each tablet) Purpose
Aspirin 81 mg (NSAID)* ........................................ Pain reliever
*nonsteroidal anti-inflammatory drug
Uses
- temporary relief of minor aches and pains or as recommended by your doctor.
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
- ask your doctor about other uses for 81 mg Aspirin
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
- shock
- facial swelling
- 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
- 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
- take more or for a longer time than directed
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
- you have asthma
- 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
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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs.
Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling present in the painful area
- new symptoms occur
These could be sign 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- drink a full glass of water with each dose
-
adults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor
-
children under 12 years: consult a doctor
Inactive ingredients
Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Questions or comments?
Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or
www.safrel.com
PRINCIPAL DISPLAY PANEL
See New Warnings Information & Directions
Compare to Bayer® Low Dose Aspirin active ingredients†
† This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer® Low Dose Aspirin.
Aspirin Enteric Coated Tablets, 81 mg
NDC 71309-003-05
NDC 71309-003-10
Safrel Pharmaceuticals, LLC.