Low Dose Aspirin: Package Insert and Label Information
LOW DOSE ASPIRIN- aspirin tablet, coated
Strategic Sourcing Services 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.
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- for the 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 safety coated 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
- facial swelling
- shock
- 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.
- if you have ever had an allergic reaction to his product or any of its ingredients
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
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stool
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever get worse or lasts more than 3 days
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
- new symptoms occur
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin at during the last 3 month 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.
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
Other information
- store between 15-30ºC (59-86ºF)
Inactive ingredients
croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid, microcrystalline cellulose 102, polacrilin potassium, polyethylene glycol 6000, polyvinyl alcohol, purified talc, silicon dioxide, sodium lauryl sulfate, soybean, titanium dioxide, triethyl citrate
Questions or comments?
Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
COMPARE TO BAYER® LOW DOSE ASPIRIN ACTIVE INGREDIENT†
LOW DOSE
Aspirin 81 mg
PAIN RELIEVER (NSAID)
Aspirin regimen±
Enteric coated±±
Safety coated±±
TABLETS
†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.
≠Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone.
≠≠Coating helps protect against stomach upset
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC. Memphis, TN 38141
www.fosterand thrive.com
Product Label
FOSTER & THRIVE Low Dose Aspirin
| LOW DOSE ASPIRIN aspirin tablet, coated | |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||
| Labeler — Strategic Sourcing Services LLC (116956644) |
Revised: 05/2023 Strategic Sourcing Services LLC
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.