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aspirin by NCS HealthCare of KY, Inc dba Vangard Labs

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7863

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.

DRUG FACTS

ACTIVE INGREDIENTS

Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug

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

Stop use and ask a doctor if

you experience the following signs of stomach bleeding:

• feel faint
• have bloody or black stools • vomit blood
• 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

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 are taking a diuretic
  • you have asthma
  • 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
• under a doctor’s care for any serious condition
• taking any other drug

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, shock, facial swelling, asthma (wheezing)

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 nonprescritpion 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 aspirin or any other pain reliever/fever reducer

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

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
  •  TAMPER EVIDENT:  DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
  • store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º-86ºF)
  • use by expiration date on package

Keep out of reach of children

 In case of overdose, get medical help or contact Poison Control Center right away

Inactive Ingredients

 BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelantinized starch, sodium saccharin, stearic acid

Purpose

 temporarily relieves minor aches and pains

Questions and comments? (800) 616-2471

Distributed by:

MAJOR®  PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

M-14

L10711115

Principal Display Panel

 

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7863(NDC:0904-6288)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
DEXTRATES 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) 
STARCH, PREGELATINIZED CORN 
SACCHARIN SODIUM 
STEARIC ACID 
ORANGE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeUPPER;tcl334;LOWER;PLAIN
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7863-3930 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34307/16/2010
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Revised: 01/2017
 
NCS HealthCare of KY, Inc dba Vangard Labs

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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