Label: ASPIRIN - aspirin tablet, extended release
- NDC Code(s): 51645-717-08
- Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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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- Active ingredient (in each tablet)
Aspirin 81 mg (NSAID*)
* nonsteroidal anti-inflammatory drugClose
- temporarily relieves minor aches and pains
- for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
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)
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
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
- you have not been drinking fluids
- you have lost a lot of fluid due to vomiting or diarrhea
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug
- under a doctor's care for any serious condition
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleedin
have bloody or black stools
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a 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 right away.
- Drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
- Other information
- Do not use if imprinted safety seal under cap is broken or missing.
- store at 250C (770 F) excursions permitted between 150-300C (590-860 F)
- Inactive ingredients:
Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, D and C Yellow #10 Aluminum Lake, Iron Oxide Ochre, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Polysorbate 80, Simethicone, Sodium Hydroxide, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate.
If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.Close
- Principal Display Panel
LOW DOSE ASPIRIN REGIMEN
- Safety Coated-Enteric Coated
- Delayed Release Aspirin Tablets
- Small, Easy-to-Swallow Tablets
*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer Low Dose.
- 81 mg each
- INGREDIENTS AND APPEARANCE
aspirin tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51645-717 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND (YELLOW) Size 7mm Flavor Imprint Code RAISED;HEART Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51645-717-08 120 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 01/10/2013 Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals (055942270) Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals (055942270)