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

Aspirin

Dolgencorp, LLC

  • 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
Rexall 44-439

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • the common cold
    • minor pain of arthrtitis
    • menstrual pain
  • or as recommended by your doctor 

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:

  • asthma (wheezing)
  • hives
  • facial swelling
  • 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 (anticoabulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxes, or others]
  • have 3 or more alcoholic drinks ever 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 or stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic 

Ask a doctor or pharmacist before use if are

 taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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 complication during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and overL 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: do not use unless directed by a doctor 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat and humidity
  • see end flap for expiration date and lot number 

Inactive ingredients

 black iron oxide, cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

Since 1903

Rexall®

Enteric Safety Coated

• Low dose
• Aspirin regimen
• Easy to swallow

81mg Aspirin
Pain Reliever (NSAID)

100 Coated Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844        REV0113B43912

Visit us at: Rexall.com
or call 1-866-4-REXALL
MANUFACTURED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA

 Principal Display Panel

Rexall 44-439A

Aspirin

Aspirin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-438
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOLS
DIMETHICONE
SODIUM ALGINATE
SODIUM BICARBONATE
STEARIC ACID
titanium dioxide
talc
triacetin
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 8 mm 44;439 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE, PLASTIC
2 NDC:55910-438-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-04-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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