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Aspirin by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on February 27, 2018

Dosage form: tablet, coated
Ingredients: ASPIRIN 325mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-0522

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 325mg

Active ingredient (in each tablet)

Aspirin 325mg (NSAID*)

*nonsteriodal anti-flammatory drug

Purpose

Pain Reliever/Fever Reducer

Uses

temporarily relieves

• headache

• toothache

• minor pain of arthritis

• muscle pain

• pain and fever of colds

• menstrual pain

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

•  shock

•  asthma(wheezing)

Stomach Bleeding Warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if the user:

• is age 60 or older

• has had stomach ulcers or bleeding problems

• takes a blood-thinning (anticoagulant) or steriod drug

• takes other drugs containing prescription or nonprescription NSAIDS (aspirin,Ibuprofen, naproxen, or others)

• takes more or for a longer time than directed

• has 3 or more alcoholic drinks every day while using this product

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer.

Ask a doctor before use if

• stomach bleeding warning applies to user

• user has a history of stomach problems, such as heartburn

• user has high blood pressure, heart disease, liver cirrhosis, or kidney disease

• user is taking a diuretic

• user has asthma

• user has not been drinking fluids

• user has lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if the user is

• taking a prescription drug for diabetes, or gout or arthritis

• taking any other drug

• under a doctor's care for any serious condition

Stop use and ask a doctor if

• user experiences any ot the following signs of stomach bleeding:

  °feels faint

   °has bloody or black stools

   °vomits blood

    °has 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: 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours.

Children under 12 years: ask a doctor

Other information

• Store at 20'- 25' C (68 - 77'F) 

• coated for easier swallowing

Inactive ingredients

Corn Starch, Croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide.

Questions or Comments?

Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

Principal Display Panel

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0522(NDC:0536-3305)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL;011
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0522-3131 TABLET, COATED (31 TABLET) in 1 BLISTER PACK
2NDC:0615-0522-3930 TABLET, COATED (30 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34309/30/2009
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-0522), REPACK(0615-0522)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Further information

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

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