aspirin tablets

aspirin tablets
SPL v1
SPL
SPL Set ID 579dc7cc-903e-4c51-be12-ba6aa0c3a74e
Route
oral
Published
Effective Date 2010-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (325 mg)

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
otc monograph final active Since 2010-08-10

Purpose

Pain reliever/fever reducer

Description

Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug


Medication Information

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 a nonsteroidal anti-inflammatory drug (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
Active Ingredient

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

Temporarily reduces fever.

Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless

    directed by a doctor (see Warnings)
  • drink a full glass of water with each dose

Adults and childre: (12 years and older)

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other Information

store at 20° to 25°C (68° to 77°F)

Description

Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Do Not Use

• if you are allergic to aspirin or any other pain reliever/fever reducer

Package Label
Blister of 30 Tablets
Questions Or Comments?

Distributed by: Marlex Pharmaceuticals, 50 McCullough Drive, New Castle, DE 19720, U.S.A.

call toll free 1-866-820-7381

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

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
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
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If

taking a prescription drug for diabetes, gout or arthritis


Structured Label Content

Warnings (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 a nonsteroidal anti-inflammatory drug (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
Active Ingredient (ACTIVE INGREDIENT (IN EACH TABLET))

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Uses (USES)

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

Temporarily reduces fever.

Purpose (PURPOSE)

Pain reliever/fever reducer

Directions (DIRECTIONS)
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless

    directed by a doctor (see Warnings)
  • drink a full glass of water with each dose

Adults and childre: (12 years and older)

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other Information (OTHER INFORMATION)

store at 20° to 25°C (68° to 77°F)

Do Not Use (Do not use)

• if you are allergic to aspirin or any other pain reliever/fever reducer

Package Label
Blister of 30 Tablets
Questions Or Comments? (QUESTIONS OR COMMENTS?)

Distributed by: Marlex Pharmaceuticals, 50 McCullough Drive, New Castle, DE 19720, U.S.A.

call toll free 1-866-820-7381

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--08/2010--NJW

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
If Pregnant Or Breast Feeding, (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. (Keep out of reach of children.)

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

taking a prescription drug for diabetes, gout or arthritis


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Raw Label Data

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