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

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Aspirin

A&Z Pharmaceutical Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Aspirin Uses

Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. Ask your doctor about other uses for Enteric Coated 81 mg Aspirin.

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
  • •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 are allergic to aspirin or any other pain reliever/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

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • •gout
  • •diabetes
  • •arthritis

Stop use and ask a doctor if

  • •an allergic reaction occurs. Seek medical right away.
  • •you experience any of the following signs of stomach bleeding:
    • ofeel faint
    • ovomit blood
    • ohave bloody or black stools
    • ohave stomach pain that does not get better
    • opain gets worse or lasts more than 10 days
    • oredness or swelling is present
    • onew symptoms occur
    • oringing in the ears or a loss of hearing occurs

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.

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

  • •save carton for full directions and warnings
  • •store at room temperature

Inactive Ingredients

Pregelatinized starch, microcrystalline cellulose, crospovidone, stearic acid, hypromellose, methacrylic acid copolymer, sodium lauryl sulfate, polysorbate, triethyl citrate, titanium dioxide, talc, FD&C Yellow No.5, Aluminum Oxide

Questions or comments?

Call toll free 1-888-952-0050 Monday through Friday 9AM-5PM

*Health A2Z® Aspirin is not manufactured or distributed by Bayer Consumer Care, distributor of Bayer®

Manufactured for:
A&Z Pharmaceutical Inc.
Deer Park, NY11729

Package/Label Principal Display Panel

Aspirin

Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-838
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
STARCH, PREGELATINIZED CORN
cellulose, microcrystalline
CROSPOVIDONE
STEARIC ACID
HYPROMELLOSES
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SODIUM LAURYL SULFATE
polysorbate 80
TRIETHYL CITRATE
titanium dioxide
talc
FD&C YELLOW NO. 5
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
YELLOW 7 mm A ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:62211-838-50 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-09-19


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Be sure to consult your doctor before taking any medication!
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