Aspirin by NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN tablet, coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WHEN USING

SPL UNCLASSIFIED SECTION

Principal Display Panel

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, coated

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-0522-31	31 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/12/2009	06/30/2015
2	NDC: 0615-0522-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/12/2009	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	09/30/2009	07/31/2020

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	REPACK(0615-0522)