Label: ASPIRIN THIN COATED- aspirin tablet
- NDC Code(s): 0904-2019-59
- Packager: Major Pharmaceuticals
- 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 October 10, 2014
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- Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
Pain reliever/fever reducer
- minor pain of arthritis
- muscle pain
- menstrual pain
- pain and fever of colds
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 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 more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription and nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have liver cirrhosis
- you have a history of stomach problems, such as heartburn
- you have heart or kidney disease
- you are taking a diuretic
- you have high blood pressure
- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
Stop use and ask a doctor if
- 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
- an allergic reaction occurs. Seek medical help right away.
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms occur
- fever gets worse or lasts more than 3 days
- 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 tuse 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (-1800-222-1222) right away.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.
- children under 12 years: consult a doctor
- Other information
- use by expiration date on package
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- Inactive ingredients
corn starch, hypromellose, polyetheylene glycol, propylene glycolClose
- Questions or comments?
- Principal display panel
†Compare to the active ingredient in Genuine Bayer® Aspirin
Fever reducer (NSAID)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer® HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
- INGREDIENTS AND APPEARANCE
ASPIRIN THIN COATED
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-2019 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 STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code ASPIRIN;44157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-2019-59 100 in 1 BOX 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 05/07/2014 Labeler - Major Pharmaceuticals (191427277)