Aspirin 81 Mg Low Dose Chewable Tablets Orange Flavor

Aspirin 81 Mg Low Dose Chewable Tablets Orange Flavor
SPL v4
SPL
SPL Set ID 5d56618c-8ea2-42ea-a9f2-339bd0055ddd
Route
ORAL
Published
Effective Date 2012-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Butylated Hydroxytoluene Dextrates Fd&c Yellow No. 6 Cellulose, Microcrystalline Modified Corn Starch (1-octenyl Succinic Anhydride) Orange Starch, Corn Saccharin Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: UPPER;tcl334;LOWER;PLAIN Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-07-16

Description

Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

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
Indications and Usage

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor

• ask your doctor about other uses for 81 mg orange chewable aspirin

Dosage and Administration

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 not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor
Description

Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever *nonsteroidal anti-inflammatory drug

Section 44425-7

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Section 50565-1

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.

Section 50566-9

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

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

ringing in the ears or a loss of hearing occurs

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis
Section 50569-3

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
Section 50570-1

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6

Inactive ingredients butylated hydroxytoluene, dextrates, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, modified corn starch, pregelatinized starch, sodium saccharin, stearic acid

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever

Active Ingredients
Active ingredient (in each tablet) Purpose



Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever



*nonsteroidal anti-inflammatory drug








Structured Label Content

Indications and Usage (34067-9)

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor

• ask your doctor about other uses for 81 mg orange chewable aspirin

Dosage and Administration (34068-7)

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 not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor
Warnings and Precautions (34071-1)

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
Section 44425-7 (44425-7)

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

ringing in the ears or a loss of hearing occurs

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)

Inactive ingredients butylated hydroxytoluene, dextrates, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, modified corn starch, pregelatinized starch, sodium saccharin, stearic acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Active Ingredients (ACTIVE INGREDIENTS)
Active ingredient (in each tablet) Purpose



Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever



*nonsteroidal anti-inflammatory drug








Advanced Ingredient Data


Raw Label Data

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