FDA Label for Aspirin 81 Mg Enteric Coated
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- OTHER SAFETY INFORMATION
- OTHER
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
Aspirin 81 Mg Enteric Coated Product Label
The following document was submitted to the FDA by the labeler of this product Quality Care Products, Llc. 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.
Active Ingredients (In Each Tablet)
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains
- ask your doctor about other uses for enteric-coated 81 mg Aspirin
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
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 symptons 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 any include:
- hives
- facial swelling
- shock
- asthma (wheezing)
Other
Somach bleeding warning: This product contains 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 steriod 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
Otc - Do Not Use
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
Otc - Ask Doctor
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
- you have not been dirinking fluids
- you have lost a lot of fluid due to vomiting or diarrhea
Ask A Doctor Or Pharmacist Before Use If You Are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug
- under a doctor's care for any serious condition
Otc - Stop Use
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:
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
These could be sings of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or brest-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 conplications 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 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 at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
Questions Or Comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
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