Aspirin 325 Mg Ec Tablet

Aspirin 325 Mg Ec Tablet
SPL v6
SPL
SPL Set ID 2ab8564f-f958-7512-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Povidone Methacrylic Acid Stearic Acid Starch, Corn Croscarmellose Sodium Fd&c Yellow No. 6 D&c Yellow No. 10 Hypromelloses Propylene Glycol Titanium Dioxide Talc Sodium Lauryl Sulfate Polyethylene Glycol 1000

Identifiers & Packaging

Pill Appearance
Imprint: AP;110 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-01

Description

Drug Facts


Medication Information

Indications and Usage

temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • toothache
  • pain and fever of colds
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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 more than 10 days
  • fever gets worse or lasta more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug
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 have ever had an allergic reaction to any other pain reliever/fever reducer

Section 51945-4

NDC 69618-015-01

Enteric Coated

Aspirin USP 325 mg (NSAID)

PAIN RELIEVER

FEVER REDUCER

100 TABLETS

*Compare to Active Ingredients in Ecotrin®

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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

Pain Reliever/Fever Reducer

Section 55106-9

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Allergy alert: Aspirin may cause a severe allergic reaction which may include

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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 prodcut, 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.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor
Other Information
  • store at room temperature 15°-30ºC (59°-86°F)
Inactive Ingredients

croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • toothache
  • pain and fever of colds
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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 more than 10 days
  • fever gets worse or lasta more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug
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 have ever had an allergic reaction to any other pain reliever/fever reducer

Section 51945-4 (51945-4)

NDC 69618-015-01

Enteric Coated

Aspirin USP 325 mg (NSAID)

PAIN RELIEVER

FEVER REDUCER

100 TABLETS

*Compare to Active Ingredients in Ecotrin®

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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)

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Allergy alert: Aspirin may cause a severe allergic reaction which may include

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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 prodcut, 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.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor
Other Information (Other information)
  • store at room temperature 15°-30ºC (59°-86°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday


Advanced Ingredient Data


Raw Label Data

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