Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a0f84fac-3f7c-45c0-a2e8-ce39fb2bd630
Route
ORAL
Published
Effective Date 2011-09-20
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 Hypromellose 2910 (6 Mpa.s) Hypromellose 2910 (15 Mpa.s) Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Cellulose, Microcrystalline Mineral Oil Polysorbate 80 Silicon Dioxide Dimethicone Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-20

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
  • shock
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed
  • has 3 or more alcoholic drinks every day while using this product
  • is age 60 or older

Indications and Usage

Uses

temporarily relieves

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

Dosage and Administration

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

Description

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

Section 44425-7

Other information

  • store at 20° - 25°C (68° - 77°F)

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

  • user experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has 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 in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

Section 50568-5

Ask a doctor or pharmacist before use if user is

  • 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 user
  • user has a history of stomach problems such as heartburn
  • user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • user is taking a diuretic
  • user has asthma
  • user has not been drinking fluids

Section 50570-1

Do not use

if you have ever had an allergic reaction to 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 copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Section 53413-1

Questions or comments?

call

1-800-645-2158, 9 am - 5 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 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves

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

Dosage and Administration (34068-7)

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

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
  • shock
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • takes more or for a longer time than directed
  • has 3 or more alcoholic drinks every day while using this product
  • is age 60 or older

Section 44425-7 (44425-7)

Other information

  • store at 20° - 25°C (68° - 77°F)

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

  • user experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has 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 in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if user is

  • 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 user
  • user has a history of stomach problems such as heartburn
  • user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • user is taking a diuretic
  • user has asthma
  • user has not been drinking fluids

Section 50570-1 (50570-1)

Do not use

if you have ever had an allergic reaction to 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 copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Section 53413-1 (53413-1)

Questions or comments?

call

1-800-645-2158, 9 am - 5 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 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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