Label: ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 70000-0253-1, 70000-0253-2, 70000-0253-3
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 21, 2018
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- Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*Close
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducerClose
- pain and fever of colds
- menstrual pain
- muscle pain
- minor pain of arthritis
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:
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- have had stomach ulcers or bleeding problems
- 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
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
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.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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.
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.
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
- children under 12 years: ask a doctor
- Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, hypromellose, polyethylene glycol, propylene glycolClose
- Questions or comments?
- Principal display panel
Aspirin, 325 mg
Pain Reliever / Fever Reducer (NSAID)
COMPARE TO GENUINE
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TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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Return to place of purchase if not satisfied.
CIN 5320874 REV. 2/17
†This product is not manufactured or distributed
by Bayer HealthCare LLC, owner of the registered
trademark Genuine Bayer® Aspirin.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Essential to Care™ since 1979
© 2017 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.
- INGREDIENTS AND APPEARANCE
aspirin tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0253 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code Aspirin;44;157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0253-1 1 in 1 CARTON 02/10/1996 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70000-0253-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996 3 NDC:70000-0253-3 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/10/1996 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(70000-0253)