ASPIRIN - aspirin tablet, coated 
NCS HealthCare of KY, Inc dba Vangard Labs

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Aspirin 325mg

Active ingredient(s)

Aspirin 325mg (NSAID)*

*nonsteriodal anti-flammatory drug

Purpose

Pain Reliever/Fever Reducer

Use(s)

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you have had stomach ulcers or bleeding problems, take a blood-thinning (anticoagulant) or steriod drug, take other drugs containing an NSAID (Ibuprofen, naproxen, or others), are age 60 or older, take more or for a longer time than directed, have 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

You have problems or serious side effects from taking pain relievers or fever reducers, high blood pressure, stomach problems that last or come back, such as heartburn, upset stomach or stomach pain, heart or kidney disease,ulcers,asthma, reaches age 60 or older, taken a diuretic, bleeding problems.

Ask a doctor or pharmacist before use if

You are taking any drug containing an NSAID (prescription or non prescription), taking a blood thinner (anticoagulant) or steroid drug, 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

you feel faint, vomit blood, or have bloody or blck stools. These are signs of stomach bleeding. Pain gets worse or lasts more than 10 days, stomach pain or upset gets worse or lasts, fever gets worse or lasts more than 3 days, any new symptoms appear, redness or swelling is present in the painful area, ringing in the ears or loss of hearing occurs.

Pregnancy/Breastfeeding

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

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.

Storage

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

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

Principal Display Panel

Aspirin (NSAID) 325mg

Principal Display Panel-Aspirin 325mg

ASPIRIN 
aspirin   tablet, coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0615-0522 (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
ColorWHITEScore no score
ShapeROUNDSize4mm
FlavorImprint Code TCL;011
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10615-0522-3131 TABLET In 1 BLISTER PACKNone
20615-0522-3930 TABLET In 1 BLISTER PACKNone

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, REPACK
Revised: 11/2010NCS HealthCare of KY, Inc dba Vangard Labs