Aspirin Low Tablets

Aspirin Low Tablets
SPL v1
SPL
SPL Set ID 466f6fa5-79f9-4f53-971d-a5254b0750e3
Route
ORAL
Published
Effective Date 2010-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)

Identifiers & Packaging

Pill Appearance
Imprint: PH;023 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-09

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product
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
Directions
  • drink a full glass of water with each dose
  • do not exceed recommended dosage
  • 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: ask a doctor
Do Not Use

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

Package Label
Blister of 30 Tablets
Other Information

store at 20° to 25°C (68° to 77°F)

Questions Or Comments?

Manufactured by:

Pharbest Pharmaceuticals

14 Engineers Lane

Farmingdale, L.I., New York

call toll free 631-249-5133

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.

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If

taking a prescription drug for diabetes, gout or arthritis


Structured Label Content

Uses (USES)
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product
Purpose (PURPOSE)

Pain reliever

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
Directions (DIRECTIONS)
  • drink a full glass of water with each dose
  • do not exceed recommended dosage
  • 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: ask a doctor
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
Other Information (OTHER INFORMATION)

store at 20° to 25°C (68° to 77°F)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Manufactured by:

Pharbest Pharmaceuticals

14 Engineers Lane

Farmingdale, L.I., New York

call toll free 631-249-5133

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.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

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


Advanced Ingredient Data


Raw Label Data

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