Aspirin Tablet, Coated
FDA Label NDC 81005-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aarkish Pharmaceuticals Nj Inc. for the product Aspirin (NDC 81005-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, other safety information, do not use, ask doctor, ask a doctor or pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains
Because of its delayed action, this product will not produce fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for enteric-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 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
- 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 steriod drug
- take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)
- have 3 or more alcoholic drinks every day while using this product

- take more or for longer time than directed

Do Not Use

Do not use: if you are allergic to aspirin or any other pain reliever/fever reducer

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 drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea

Ask A Doctor Or Pharmacist

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

Stop Use

Stop use and ask a doctor if

 - an allergic reaction occurs. Seek medical help right away.
- you are 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
- 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.
these could be signs of a serious condition.

Pregnancy Or Breastfeeding

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

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

Storage

- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- Use by expiration date on package

Inactive Ingredients

corn starch, pregelatinized starch, povidone, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, D&C yellow #10, hypromellose, triacetin.

Principal Display Panel

Aspirin Tablets, 81 mg, 300 counts

Aspirin-cont-label-1-front.jpg (Aspirin Cont Label 1 Front.jpg)

Aspirin-cont-label-1-front.jpg (Aspirin Cont Label 1 Front.jpg)

Aspirin-cont-label-1-back.jpg (Aspirin Cont Label 1 Back.jpg)

Aspirin-cont-label-1-back.jpg (Aspirin Cont Label 1 Back.jpg)

Aspirin Tablets, 81 mg, 1000 counts

Aspirin-cont-label-2-front.jpg (Aspirin Cont Label 2 Front.jpg)

Aspirin-cont-label-2-front.jpg (Aspirin Cont Label 2 Front.jpg)

Aspirin-cont-label-2-back.jpg (Aspirin Cont Label 2 Back.jpg)

Aspirin-cont-label-2-back.jpg (Aspirin Cont Label 2 Back.jpg)

* Please review the disclaimer below.