Label: ASPIRIN tablet
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 27, 2014
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- Active ingredient (in each tablet)
- INDICATIONS & USAGE
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
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
Do not use
if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
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 • vomit blood • have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
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.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-096 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) D&C RED NO. 6 (UNII: 481744AI4O) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code PH024 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-096-53 1 in 1 CARTON 1 125 in 1 BOTTLE 2 NDC:49781-096-58 300 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 09/20/2014 Labeler - CARDINAL HEALTH (097537435) Registrant - Pharbest Pharmaceuticals, Inc. (557054835)