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care one aspirin

American Sales Company

American Sales Company Aspirin 81 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

care one aspirin 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 pain reliever/fever reducer
  • •for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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

  • •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
  • •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
  • •new symptoms occur
  • •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. (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 while symptoms persist.

Do not exceed 48 tablets in 24 hours or as directed by a doctor.

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

Other information

  • • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow #6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Active Ingredient in St. Joseph®

Chewable Orange Flavor

ASPIRIN 81 mg

ADULT LOW STRENGTH - ASPIRIN REGIMEN

Actual Size

Pain Reliever (NSAID)

81 mg Each

care one aspirin

Aspirin TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-259
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
saccharin sodium
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Light Orange) 8 mm L467 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 36 in 1 BOTTLE
2 NDC:41520-259-68 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-11-22


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Be sure to consult your doctor before taking any medication!
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