481r Tcl 49483-481 Aspirin 81mg Delayed Release Tablets

481r Tcl 49483-481 Aspirin 81mg Delayed Release Tablets
SPL v2
SPL
SPL Set ID 16595d62-8507-103c-e063-6394a90a491a
Route
ORAL
Published
Effective Date 2015-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
D&c Yellow No. 10 Aluminum Lake Sodium Hydroxide Anhydrous Lactose Carnauba Wax Silicon Dioxide Brown Iron Oxide Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Dimethicone Sodium Lauryl Sulfate Starch, Corn Talc Titanium Dioxide Triethyl Citrate Microcrystalline Cellulose Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: HEART Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredient (in each tablet) Aspirin 81 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
  • asthma (wheezing)
  • shock

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

for the temporary relief of minor aches and pains or as recommended by your doctor 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 81 mg Aspirin

Dosage and Administration

Directions

  • drink a full glass of water with each dose
  • 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: consult a doctor

Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Section 50565-1

Keep out of reach of children.In case of 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

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 lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
Section 50568-5

Ask a doctor or pharmacist before use if you aretaking a prescription drug for: ­

  • gout ­
  • diabetes ­
  • arthritis

Section 50569-3

Ask a doctor before use if

  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic ­
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Section 50570-1

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008 9:00 AM-5:00 PM ET,

Monday-Friday

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 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • avoid excessive heat above 40°C (104°F)


Structured Label Content

Indications and Usage (34067-9)

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor 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 81 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 4 to 8 tablets every 4 hours not to exceed 48 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
  • asthma (wheezing)
  • shock

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 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

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 lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking a prescription drug for: ­

  • gout ­
  • diabetes ­
  • arthritis

Section 50569-3 (50569-3)

Ask a doctor before use if

  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic ­
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Section 50570-1 (50570-1)

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008 9:00 AM-5:00 PM ET,

Monday-Friday

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 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information (OTHER INFORMATION)

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • avoid excessive heat above 40°C (104°F)


Advanced Ingredient Data


Raw Label Data

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