Aspirin description, usages, side effects, indications, overdosage, supplying and lots more!

Aspirin

NCS HealthCare of KY, Inc dba Vangard Labs

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Aspirin EC 81 mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

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. 

Uses

-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

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.

Allergy Alert

Alergy Alert:  Aspirin may cause a severe allergic reaction which may include:  Hives, facial swelling, asthma (wheezing), shock.

Stomach Bleeding Warning

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

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.

If pregnant or breastfeeding

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.

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.

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

Other information

store at 25ºC (77ºF) excursions permitted between 15º-30ºC (59º-86ºF)

use by expiration date on package

**Compare to the active ingredient in BAYER® Low Dose

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose.

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive,

Livonia, MI 48150 USA

Principal Display Panel

Aspirin EC Tablets 81mg

Principal Display Panel

Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label 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 81 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
polysorbate 80
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE
DIMETHICONE
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Shape
YELLOW 7 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-3568-31 31 in 1 BLISTER PACK
2 NDC:0615-3568-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-08-05


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Be sure to consult your doctor before taking any medication!
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