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aspirin by NCS HealthCare of KY, Inc dba Vangard Labs

Dosage form: tablet, chewable
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.

Aspirin Chewable Tabs 81mg - 7863

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

Stop use and ask a doctor if
  • you experience any of 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
• taking any other drug

• under a doctor’s care for any serious condition

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
  • 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, pregelatinized starch, sodium saccharin, stearic acid

Questions or comments? (800) 616-2471

Distributed by:

MAJOR®  PHARMACEUTICALS

17177 N Laurel Park Dr.,Suite 233

Livonia, MI 48152 USA

M-14

L700313.01 Rev. 03/17

Principal Display Panel

 

ASPIRIN 
aspirin tablet, chewable
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, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34306/19/2018
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-7863), REPACK(0615-7863)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Medically reviewed on Aug 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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