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

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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

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

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 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 diabetes, gout, or arthritis.

Stop use and ask a doctor if

  • 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 more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • 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

  • adults and children 12 years of age or over: take 1 to 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 of age: ask a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

corn starch, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?

1-800-632-6900

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of ECOTRIN®  **See side panel

Aspirin 325 mg

Pain Reliever (NSAID)*

REGULAR STRENGTH ENTERIC COATED Aspirin Regimen

TABLETS 325 mg EACH

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

**Ecotrin® is a registered trademark of Prestige Brands, Inc., Irvington, NY 10533. Prestige Brands, Inc. is not affiliated with The Kroger Co. or this product.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Package Label
Kroger Aspirin 325 mg Tablet

Aspirin

Aspirin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-370
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, CORN
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
cellulose, microcrystalline
Mineral Oil
polysorbate 80
DIMETHICONE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 11 mm T ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 125 in 1 BOTTLE, PLASTIC
2 NDC:30142-370-12 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-01-10


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Be sure to consult your doctor before taking any medication!
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