FDA Label for Adult Low Dose Aspirin
View Indications, Usage & Precautions
Adult Low Dose Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, 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.
Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing.
Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID)*..................................Pain reliever
*nonsteroidal anti-inflammatory drug
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 headache or 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 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
- shock
- facial swelling
- asthma (wheezing)
- 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
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you:
Do Not Use
- if you are allergic to aspirin, or any other pain reliever/fever reducer
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 doctor
- children under 12 years: ask a doctor
- store at room temperature 15-30°C (59-86°F)
Other information
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, D&C yellow 10, iron oxide yellow 6, lactose, methacrylic acid and ethyl acrylate copolymer,
microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate
Package Label.Principal Display Panel
Adult Low Dose
Aspirin
81 mg
NDC 57237-349-12
120 Tablets
* Please review the disclaimer below.
