Your browser does not support JavaScript! ASPIRIN TABLET, EXTENDED RELEASE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMACEUTICALS]
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RxNorm Names

ASPIRIN tablet, extended release
[Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • 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

Warnings

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:
  • 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

Do not use

  • if you are allergic to aspirin or 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
  • 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

                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
  • 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.

Directions:

  • 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.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

PlusPHARMA
ASPIRIN
81 mg
NSAID
PAIN RELIEVER
LOW DOSE ASPIRIN REGIMEN
  • Safety Coated-Enteric Coated
  • Delayed Release Aspirin Tablets
  • Small, Easy-to-Swallow Tablets
*Compare to the active ingredient in Bayer Low Dose
*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer Low Dose.
120 TABLETS
  • 81 mg each
    Untitled.jpg
    Untitled1.jpg
ASPIRIN  
aspirin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-717
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUND (YELLOW) Size7mm
FlavorImprint Code RAISED;HEART
Contains    
Packaging
#Item CodePackage Description
1NDC:51645-717-08120 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/10/2013
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals (055942270)
Registrant - Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals (055942270)

Revised: 01/2013
Document Id: b4c5bc15-419e-44b3-89e5-ddfc11a9612e
Set id: ee75c6c2-56c9-4507-b792-d154661c6a13
Version: 1
Effective Time: 20130110
 
Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals

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