FDA Label for Aspirin
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.
Drug Facts
Aspirin 81 mg (NSAID*)
Otc - Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain reliever
Indications & Usage
Uses
•temporarily relieves minor aches and pains
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 enteric-coated 81 mg Aspirin
Warnings
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
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 drinking fluids
•you have lost a lot of fluid due to vomiting or diarrhea
Otc - Ask Doctor/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
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:
•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.
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 right away.(1-800-222-1222)
Dosage & Administration
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
Other information
•store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
•use by expiration date on package
Inactive Ingredient
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
Otc - Questions
Call 1-800-632-6900
* Please review the disclaimer below.