Label: ASPIRIN- aspirin 325 mg tablet
- NDC Code(s): 69168-312-01, 69168-312-17
- Packager: Allegiant Health
- 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 November 7, 2018
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- Active ingredient
Aspirin 325 mg (NSAID*)Close
*nonsteroidal anti-inflammatory drug
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.Close
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, facial swelling, asthma (wheezing), shock.
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 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 aspirinor 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for anticoagulation (thinning the blood) diabetes gout arthritis
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 new symptoms occur ringing in the ears or loss of hearing occurs
You may report side effects to 1-888-952-0050
- Keep Out of Reach of Children
In case of accidental overdose, get medical help or contact a PoisonControlCenter right away.Close
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
- children under 12 years: do not use unless directed by a doctor
- Inactive Ingredients
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
aspirin 325 mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-312 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) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-312-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014 2 NDC:69168-312-17 300 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 12/18/2014 Labeler - Allegiant Health (079501930)