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Regular Strength Aspirin EC by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on February 26, 2018

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 325mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-0564

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.

Aspirin NSAIDS EC Tablet 325mg- 5gr

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

REGULAR STRENGTH ASPIRIN EC 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0564(NDC:0904-2013)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE 2910 (6 MPA.S) 
HYPROMELLOSE 2910 (15 MPA.S) 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYSORBATE 80 
SILICON DIOXIDE 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeT
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0564-3930 TABLET, DELAYED RELEASE (30 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34309/09/2011
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-0564), REPACK(0615-0564)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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