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

Purpose

Pain reliever

Description

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


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.
Active Ingredient

Aspirin (NSAID)* 325 mg

*nonsteroidal anti-inflammatory drug

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

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

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

Principal Display Panel

Compare to the active ingredient in

ECOTRIN ® TABLETS*

REGULAR STRENGTH

ASPIRIN

PAIN RELIEVER (NSAID)

300 TABLETS

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

Do Not Use

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

Questions Or Comments?

1(888)333-9792

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.

Ask A Doctor Or Phamracist Before Use If You Are

taking a prescription drug for diabetis, gout or arthritis


Structured Label Content

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.
Active Ingredient (Active ingredient (in each tablet))

Aspirin (NSAID)* 325 mg

*nonsteroidal anti-inflammatory drug

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
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
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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in

ECOTRIN ® TABLETS*

REGULAR STRENGTH

ASPIRIN

PAIN RELIEVER (NSAID)

300 TABLETS

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

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

1(888)333-9792

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.

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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