Label: CVS ASPIRIN - aspirin tablet
- NDC Code(s): 59779-227-12, 59779-227-13
- Packager: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts
- Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
- for temporary relief of minor aches and pains due to:
- muscle pain
- menstrual pain
- the common cold
- minor pain of arthritis
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.
Aspirin may cause a sever allergic reaction, which may include:
- facial swelling
- asthma (wheezing)
Stomach bleeding warning:
This product contains and (NSAID), which may cause sever 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
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 sirrhosis, or kidney disease
- you have asthma
- you are taking a diurretic
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
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition.
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 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 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
- Other Information
- store in a coool dry place at controlled room temperature 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- Inactive Ingredients
black iron oxide, cellulose, colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrateClose
- PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Compare to the active ingredient
in Regulare Strength Ecotrin®†
See New Warnings
ALWAYS SAFETY COATED
ASPIRIN REGIMEN-PAIN RELIEVER (NSAID)
325 mg Regular Strength
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2010 CVS/pharmacy
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-227 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (Aspirin) Aspirin 325 mg Inactive Ingredients Ingredient Name Strength Ferrosoferric Oxide Silicon Dioxide D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose Polydextrose Polyethylene Glycol Propylene Glycol Sodium Alginate Sodium Bicarbonate Stearic Acid Talc Titanium Dioxide Triacetin Triethyl Citrate Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-227-12 1 in 1 CARTON 1 100 in 1 BOTTLE, PLASTIC 2 NDC:59779-227-13 1 in 1 CARTON 2 250 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/14/1992 Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574) Registrant - L.N.K. International, Inc. (832867837) Establishment Name Address ID/FEI Business Operations L.N.K. International, Inc 832867894 MANUFACTURE