331r Timely 49483-331 Aspirin 325mg Delayed Release Tablets

331r Timely 49483-331 Aspirin 325mg Delayed Release Tablets
SPL v8
SPL
SPL Set ID 5fbd8bb3-46f9-4089-9a21-b6af97a06106
Route
ORAL
Published
Effective Date 2021-10-04
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 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Mineral Oil Polysorbate 80 Dimethicone Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate Hypromelloses

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-04

Description

Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an 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
Indications and Usage

Uses

  • temporarily relieves minor aches and pains

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • ask your doctor about other uses for enteric-coated 325 mg Aspirin
Dosage and Administration

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Description

Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

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

These could be signs 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
  • taking any other drug
  • under a doctor’s care for any serious condition

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
  • ou have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Section 50570-1

Do not use

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

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments? call 1-877-290-4008

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever

Section 55106-9

Active ingredient (in each tablet)

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

Section 60561-8

Other information

  • each tablet contains: sodium 1 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • ask your doctor about other uses for enteric-coated 325 mg Aspirin
Dosage and Administration (34068-7)

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Warnings and Precautions (34071-1)

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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an 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
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

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

These could be signs 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
  • taking any other drug
  • under a doctor’s care for any serious condition

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
  • ou have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Section 50570-1 (50570-1)

Do not use

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? call 1-877-290-4008

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

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

Section 60561-8 (60561-8)

Other information

  • each tablet contains: sodium 1 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package


Advanced Ingredient Data


Raw Label Data

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