REGULAR STRENGTH ASPIRIN EC- aspirin tablet, delayed release

Regular Strength Aspirin EC by

Drug Labeling and Warnings

Regular Strength Aspirin EC 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(s)

 Aspirin 325mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

 Pain reliever

Use(s)

 for the temporary relief of minor aches and pains due to headache, menstrual pain, colds, toothache, muscle pain, minor pain of arthritis or as directed by a doctor.

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 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.

For external use only

Do not use

 If you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

 stomache bleeding warning applies to you, you have a history of stomach problems, such as heartburn, you have high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma, you have not been drinking fluids

Ask a doctor or pharmacist before use if

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

taking any other drug

under a doctor's care for any serious condition

When using this product

Stop use and ask a doctor if

 you expierence any of the following signs of stomach bleeding:

feel faint, have bloody or black stools, vomit blood, have stomcah 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.

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

 In case of overdose, get medical help or contact a Poison Control Center right away (1-2800-222-1222).

Directions

 drink a full glass of water with each dose, adults and children 12 years and over take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor, children under 12 years: consult a doctor

Other information

 store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F), use by expiration date on package

Storage

Inactive ingredients

corn starch, croscarmellose sodium, D & C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hyromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simehticone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions

 Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

 Aspirin (NSAID*) EC Tabs 325mg (5gr)

*nonsteroidal anti-inflammatory drug

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH ASPIRIN EC 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-0564(NDC:0904-2013)
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-0564-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	09/09/2011

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(0615-0564) , REPACK(0615-0564)