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

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Aspirin

A&Z Pharmaceutical, Inc.
A&Z Pharmaceutical, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever

  • •temporarily relieves minor aches and pains due to:
  • •headache
  • •minor arthritis pain
  • •toothache
  • •menstrual pain
  • •colds
  • •or as recommended by a doctor

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.

Aspirin may cause a severe allergic reaction which may include:

  • •hives
  • •shock
  • •facial swelling
  • •asthma (wheezing)

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

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

  • •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

taking a prescription drug for

  • •diabetes
  • •gout
  • •arthritis
  • •an allergic reaction occurs. Seek medical help 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
  • •pain gets worse or lasts more than 10 days
  • •redness or swelling is present
  • •any new symptoms occur
  • •ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.

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.

  • •adults and children 12 years of age and over: take 1 or 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose
  • •do not take more than 12 tablets in 24 hours unless directed by a doctor
  • •children under 12 years: ask a doctor.
  • •Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
  • •store below 25ºC (77ºF)

Pregelatinized starch, microcrystalline cellulose, crospovidone, stearic acid, hypromellose, methacrylic acid copolymer, sodium lauryl sulfate, polysorbate, triethyl citrate, titanium dioxide, talc, FD&C red No.40, FD&C yellow No.5, FD&C yellow No.6, Aluminum Oxide

Call Toll Free 1-888-952-0050 Monday through Friday 9AM-5PM

A&Z Pharmaceutical Inc.
Deer Park, NY 11729

Package/Label Principal Display Panel

Aspirin

Aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62211-839
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 325 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, PREGELATINIZED CORN
cellulose, microcrystalline
CROSPOVIDONE
STEARIC ACID
Hypromellose 2910 (5 Mpa.s)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SODIUM LAURYL SULFATE
polysorbate 80
TRIETHYL CITRATE
titanium dioxide
talc
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 10 mm A ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 40 in 1 BOTTLE
2 NDC:62211-839-40 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-11-26


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Be sure to consult your doctor before taking any medication!
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