Label: ASPIRIN tablet, coated
- 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 April 17, 2011
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- Drug Facts
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)
Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.
Ask a doctor before use if you have
- stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back or allergic reaction to aspirin
- bleeding problems
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- anticoagulation ( thinning of blood)
Stop use and ask a doctor if
- An allergic reaction occurs. Seek medical help right away
- Pain gets worse or lasts more than 10 days
- Redness or swelling is present
- 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 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
aspirin tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-111 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color ORANGE (ORANGE) Score no score Shape ROUND (Round) Size 11mm Flavor Imprint Code C;11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52204-111-99 41026 in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 11/15/2010 Labeler - Cispharma, Inc (833171445) Registrant - Cispharma, Inc (833171445) Establishment Name Address ID/FEI Business Operations Cispharma, Inc 833171445 manufacture