SPL v6
SPL
SPL Set ID 51b11ee1-f881-4e12-8298-6994414ce0f7
Route
ORAL
Published
Effective Date 2018-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-01-04

Description

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

How Supplied

Product: 50090-2957 NDC: 50090-2957-0 1 TABLET, DELAYED RELEASE in a BLISTER PACK / 50 in a BOX, UNIT-DOSE


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, asthmaaa9wheezing)

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

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

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

How Supplied

Product: 50090-2957

NDC: 50090-2957-0 1 TABLET, DELAYED RELEASE in a BLISTER PACK / 50 in a BOX, UNIT-DOSE

Description

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 44425-7
Other information

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

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

  • 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
  • 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 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
  • you have not been drinking fluids

Section 50570-1
Do not use

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

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

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

Pain Reliever

Section 55106-9

In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug

Aspirin

Structured Label Content

Indications and Usage (34067-9)

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

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, asthmaaa9wheezing)

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 44425-7 (44425-7)
Other information

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

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

  • 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
  • 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 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
  • you have not been drinking fluids

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)

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 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)

Pain Reliever

Section 55106-9 (55106-9)

In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug

Aspirin
How Supplied (HOW SUPPLIED)

Product: 50090-2957

NDC: 50090-2957-0 1 TABLET, DELAYED RELEASE in a BLISTER PACK / 50 in a BOX, UNIT-DOSE


Advanced Ingredient Data


Raw Label Data

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