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

Aspirin

THE KROGER CO

  • 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
DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Aspirin 81mg (NSAID)*

*nonsteroidal anti- inflammatory drug

 Pain reliever

  •  temporarily relieves minor aches and pains
  • other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 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:

  • anticoagulation (thinning of the blood)
  • gout
  • diabetes
  • arthritis
  • 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
  • allergic reaction occurs
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area

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.

In case of overdose, get medical help or contact a Poison Control Center right away. 

  • do not exceed recommended dosage
  • drink a full glass of water with each dose
  • adults and children 12 years of age 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 of age: consult a doctor
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • †Bayer® Aspirin is a trademark of Bayer Healthcare LLC (Morristown,NJ 07960). Bayer Healthcare LLC is not affiliated with The Kroger Co. or this product.

*acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron
oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, and triethyl citrate. *May also contain.

1-800-632-6900

Principal Display Panel

 KROGER®

Delayed Release

Pain Reliever (NSAID)*

Aspirin 81 mg

ADULT LOW DOSE

Aspirin Regimen

ENTERIC SAFETY- COATED TABLETS

Compare to Aspirin Regimen BAYER® 81 mg active ingredient ®†

SEE NEW WARNINGS INFORMATION

Product Label

Product Label

Aspirin 81 mg
 

Aspirin

Aspirin TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-440
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
STARCH, CORN
CROSCARMELLOSE SODIUM
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 glycol 400
polysorbate 80
POVIDONES
STARCH, CORN
propylene glycol
DIMETHICONE
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
talc
titanium dioxide
triacetin
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
YELLOW (ENTERIC COATED) 10 mm E;heart;81 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 200 in 1 BOTTLE
3 NDC:30142-440-03 300 in 1 BOTTLE
4 NDC:30142-440-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2004-02-24


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Be sure to consult your doctor before taking any medication!
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