FDA Label for Adult Low Dose Aspirin
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- ALLERGY ALERT:
- STOMACH BLEEDING WARNING:
- DO NOT USE
- REYE'S SYNDROME:
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE CONDITIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- DISTRIBUTED BY:
- PRINCIPAL DISPLAY PANEL
Adult Low Dose Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Felicific Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose
Pain reliever
Uses
- temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.
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
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.
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.
- 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
Seek medical help right away.
These could be sign of a serious condition
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
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 while symptoms last
- do not take more than 48 tablets in 24 hours unless directed by a doctor
- children under 12 years:ask a doctor
Storage Conditions
- store at room temperature 20-25°C (68-77°F)
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredients
Starch, Povidone, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl acrylate Co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6.
Questions Or Comments?
Please contact us at [email protected]
Distributed By:
Heivy ®of Felicific Inc
Queens, NY 11435
www.heivy.com
Made in the USA
Principal Display Panel
NDC 84014-531-03
Heivy ®
Compare to Bayer ®Low Dose Aspirin active ingredients*
Adult Low Dose Aspirin Delayed Release Tablets, 81 mg
Pain Reliever (NSAID)
Enteric Coated
300 Tablets
*This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer ®Low Dose Aspirin.
* Please review the disclaimer below.