Aspirin 325 Mg Tablets

Aspirin 325 Mg Tablets
SPL v6
SPL
SPL Set ID a9cf438d-b424-4b40-9cc2-16202a70accc
Route
ORAL
Published
Effective Date 2020-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Microcrystalline Cellulose Mineral Oil Polysorbate 80 Dimethicone Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-02

Description

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

Purpose

Pain reliever


Medication Information

Warnings and Precautions

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
  • shock
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:  This product contains an NSAID, which may cause  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
  • temporary relieves minor aches and pains due to: 
  • headache 
  • minor arthritis pain
  • toothache
  • menstrual pain
  • colds
  •  or as recommended by a doctor
Purpose

Pain reliever

Description

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

Section 51727-6

corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

Directions
  • adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
  •  do not take more than 12 tablets in 24 hours unless directed by a doctor
  •  children under 12 years of age: ask a doctor
Do Not Use

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Other Information
  • store below 25 0C (77 0F)
  • Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken
Questions Or Comments?

1(888)333-9792

Principal Display Panel

Compare to the active ingredient in

ECOTRIN ® TABLETS*

REGULAR STRENGTH

ASPIRIN

PAIN RELIEVER (NSAID)

300 TABLETS

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
Stop Use and Ask A Doctor If
  • 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
  • redness or swelling is present
  • any new symptom appear
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

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

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.

Active Ingredient (in Each Tablet)

Aspirin (NSAID)* 325 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Phamracist Before Use If You Are

taking a prescription drug for diabetis, gout or arthritis


Structured Label Content

Indications and Usage (34067-9)
  • temporary relieves minor aches and pains due to: 
  • headache 
  • minor arthritis pain
  • toothache
  • menstrual pain
  • colds
  •  or as recommended by a doctor
Warnings and Precautions (34071-1)

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
  • shock
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:  This product contains an NSAID, which may cause  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 51727-6 (51727-6)

corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

Purpose

Pain reliever

Directions
  • adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
  •  do not take more than 12 tablets in 24 hours unless directed by a doctor
  •  children under 12 years of age: ask a doctor
Do Not Use (Do not use)

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Other Information (Other information)
  • store below 25 0C (77 0F)
  • Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken
Questions Or Comments? (Questions or comments?)

1(888)333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in

ECOTRIN ® TABLETS*

REGULAR STRENGTH

ASPIRIN

PAIN RELIEVER (NSAID)

300 TABLETS

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
  • you have asthma
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
  • redness or swelling is present
  • any new symptom appear
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

Keep Out of Reach of Children (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

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin (NSAID)* 325 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Phamracist Before Use If You Are (Ask a doctor or phamracist before use if you are)

taking a prescription drug for diabetis, gout or arthritis


Advanced Ingredient Data


Raw Label Data

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