ASPIRIN CHEWABLE- aspirin tablet
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(s)

Aspirin 81mg (NSAID)*

*nonsteriodal anti-inflammatory drug

Purpose

Pain Reliever

Use(s)

for the temporary relief of minor aches and pains.

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 are rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: facial swelling, hives, asthma (wheezing), shock

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 nonprescription 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 have ever had an allergic reaction to any other pain reliever/fever reducer for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor.

Ask a doctor before use if

You have high blood pressure, heart disease, liver cirrhosis, or kidney disease, stomach bleeding warning applies to you , you have a history of stomach problems, such as heartburn, you are taking a diuretic, you have asthma.

Ask a doctor or pharmacist before use if

If you are taking a prescription drug for diabetes, gout or arthritis.

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away. If you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, pain gets worse or lasts for more than 10 days, redness or swelling is present, new symproms appear, ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.

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 prignancy 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. (1-800-222-1222).

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: ask a doctor.

Storage

Store a 20 - 25 degrees C (68 - 77 degrees F)

Inactive ingredients

dextrose excipient, FD&C yellow no. 6 lake, flavors,saccharin sodium, starch

Questions

Questions or Comments? 1-800-616-2471

Principal Display Panel

Aspirin 81mg Chewable Tablets

ASPIRIN CHEWABLE
aspirin chewable tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0615-3508(NDC:0904-4040)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (ASPIRIN)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DEXTROSE
FD&C YELLOW NO. 6
SACCHARIN SODIUM DIHYDRATE
STARCH, CORN

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code	L;467
Contains

Packaging
#	Item Code	Package Description
1	NDC:0615-3508-31	31 in 1 BLISTER PACK
2	NDC:0615-3508-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	04/30/2010

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(0615-3508), REPACK(0615-3508)

Revised: 12/2011

Document Id: 417203b7-4301-4836-93df-565dacd79079

Set id: 0cb8bbbf-c367-4547-80d5-013023f0d5ca

Version: 2

Effective Time: 20111207

NCS HealthCare of KY, Inc dba Vangard Labs