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

Regular Strength Buffered Aspirin

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

  • 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
CVS 44-183

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Buffered aspirin equal to 325 mg aspirin (NSAID)*.
(buffered with magnesium carbonate, calcium carbonate and magnesium oxide)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains associated with:

    • muscular aches backache

    • headache

    • minor pain of arthritis

    • backache

    • toothache

    • the common cold

    • premenstrual & menstrual cramps

  • temporarily reduces fever

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 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 of 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 you 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

  • vomit blood

  • have bloody or black stools

  • have stomach pain that does not get better

  • an allergic reaction occurs

  • symptoms do not improve

  • 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 complications during delivery.

Keep out of reach of children.

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

Directions

  • adults and children 12 years and over: 2 tablets with a full glass of water. Dosage may be repeated every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless directed by a doctor.

  • children under 12 years: do not use unless directed by a doctor

Other information

  • each tablet contains: calcium 35 mg and magnesium 40 mg

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

  • see end flap for expiration date and lot number

Inactive ingredients

citric acid, corn starch, dibasic sodium phosphate, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions or comments?

To Report Adverse Drug Event Call: 1-800-426-9391

Principal Display Panel

CVS
pharmacy®

Compare to the active ingredient in Bufferin®†

Regular Strength
BUFFERED ASPIRIN
GENTLE ON YOUR STOMACH

ASPIRIN 325 mg/PAIN RELIEVER/FEVER REDUCER (NSAID)

130 COATED TABLETS

Easy to swallow

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

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Bufferin®.

50844    REV1110B18330

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2012 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

Principal Display Panel
CVS 44-183

Regular Strength Buffered Aspirin

Aspirin TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-183
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
CITRIC ACID MONOHYDRATE
HYPROMELLOSES
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
DIMETHICONE
SODIUM LAURYL SULFATE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 11 mm 44;183 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 130 in 1 BOTTLE, PLASTIC
2 NDC:59779-183-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1990-03-30


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Be sure to consult your doctor before taking any medication!
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