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Name:Aspirin
Manufacturer:Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Category:Over-the-counter (OTC) Marketed Drugs


Aspirin EC

ASPIRIN - 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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Aspirin EC

Active ingredient(s)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Use(s)

-temporarily relieves minor aches and pains -for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Warnings

Alergy Alert: 

Aspirin may cause a severe allergic reaction which may include:  Hives, facial swelling, 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.

Reye's Syndrome

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.

Ask a doctor before use if

stomach 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, you have lost a lot of fluid due to vomiting or diarrhea.

Ask a doctor or pharmacist before use if

you are taking a prescription drug for gout, diabetes, or arthritis. under a doctor's care for any serious condition, taking any other drug.

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding: feel faint, have a bloody or black stools, vomit blood, have 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 symproms appear, riinging 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 SPECIFICALLY 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 accidential overdose, get medical help or contact a Poison Control Center right away.

Do not use

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

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 : consult a doctor.

Other information

Use by expiration date on package.

Storage

Store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees - 30 degrees C (59 degrees - 86 degrees F).

Inactive ingredients

anhydrous lactose, camauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow #10 aluminum lake, iron oxide ochre, methacryllic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethylcitrate.

Questions

Adverse drug event call: (800) 616-2471

distributed by Majpr Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA

Principal Display Panel

Aspirin EC Tablets 81mg

Principal Display Panel-Aspirin 81mg EC Tabs

ASPIRIN 
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-3568(NDC:0904-7704)
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 LACTOSE  
CARNAUBA WAX  
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FERRIC OXIDE YELLOW  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
SODIUM HYDROXIDE  
SODIUM LAURYL SULFATE  
TALC  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code L
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-3568-31 31 TABLET (31 TABLET) in 1 BLISTER PACK None
2 NDC:0615-3568-39 30 TABLET (30 TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 08/05/2010

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

Revised: 10/2010 NCS HealthCare of KY, Inc dba Vangard Labs



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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