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

Aspirin

AAA Pharmaceutical, Inc.

  • 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 Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAIDnonsteroidal anti-inflammatory drug)

Purpose

Pain reliever

Uses

  • temporarily relieves minor aches and pains

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 have ever had an allergic reaction to 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 help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

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 (1-800-222-1222).

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; do not exceed 48 tablets in 24 hours
  • children under 12 years: do not use unless directed by a doctor

Other information

  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

acetylated monoglycerides, anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, hypromellose phthalate, iron oxide yellow, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton

RESTORE u

NDC 57344-146-01

COMPARE TO THE ACTIVE
INGREDIENT IN ST JOSEPH®
SAFETY COATED ASPIRIN

ADULT
LOW DOSE

Safety
Coated

Aspirin
Pain Reliever
(NSAID)

81mg

180 ENTERIC COATED TABLETS - 81 mg each

PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton

Aspirin

ASPIRIN TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57344-146
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
DIACETYLATED MONOGLYCERIDES
ANHYDROUS LACTOSE
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
FERRIC OXIDE YELLOW
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
cellulose, microcrystalline
Mineral Oil
POLYETHYLENE GLYCOLS
polysorbate 80
DIMETHICONE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE (PEACH) 7 mm heart ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 180 in 1 BOTTLE, PLASTIC
2 300 in 1 BOTTLE, PLASTIC
3 100 in 1 BOTTLE, PLASTIC
4 180 in 1 BOTTLE, PLASTIC
5 NDC:57344-146-05 300 in 1 BOTTLE, PLASTIC
6 NDC:57344-146-06 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-12-15


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Be sure to consult your doctor before taking any medication!
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