Aspirin Tablet
FDA Label NDC 70677-1245
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Aspirin (NDC 70677-1245). 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 drug facts, active ingredient (in each tablet) aspirin 81 mg (nsaid) nonsteroidal anti-inflammatory drug, purposepain 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 this product., warningsreye'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 • asthma (wheezing) • shock stomach bleeding warning: this product contains an nsaid, which may cause 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 this 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 aretaking a prescription drug for: • gout • diabetes • arthritis, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet) Aspirin 81 Mg (Nsaid) Nonsteroidal Anti-Inflammatory Drug
Purposepain 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 This Product.
Warningsreye'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 • Asthma (Wheezing) • Shock Stomach Bleeding Warning: This Product Contains An Nsaid, Which May Cause 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 This 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 Aretaking A Prescription Drug For: • Gout • Diabetes • Arthritis
Stop Use And Ask A Doctor If• An Allergic Reaction Occurs. Seek Medical Right Away. • You Experience Any Of The Following Signs Of Stomach Bleeding: • Feel Faint • Vomit Blood • Have Bloody Or Black Stools • 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 • New Symptoms Occur • Ringing In The Ears Or A Loss Of Hearing Occurs
If Pregnant Or Breast-Feeding,Ask A Health Professional Before Use. It Is Especially Important Not To Use Aspirin At 20 Weeks Or Later In 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 At 25°C (77°F); Excursions Permitted Between 15°C To 30°C (59°F To 86°F)
Inactive Ingredients Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10 Aluminum Lake, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide Of Iron
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