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

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-0522(NDC:0536-3305)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (ASPIRIN)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code	TCL;011
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-0522-31	31 in 1 BLISTER PACK
2	NDC:0615-0522-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	09/30/2009

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-0522), REPACK(0615-0522)

Revised: 04/2012

Document Id: ff42b602-6dd1-4d90-a63b-1065333acb3d

Set id: 5441bffb-b2e5-4b65-bdde-a1d072d683db

Version: 5

Effective Time: 20120423

NCS HealthCare of KY, Inc dba Vangard Labs