011r Winco Foods 67091 382 Aspirin Tablet 325mg 100 Ct And 300ct

011r Winco Foods 67091 382 Aspirin Tablet 325mg 100 Ct And 300ct
SPL v3
SPL
SPL Set ID c34eb357-9ecd-7291-e053-2995a90a3f8c
Route
ORAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Starch, Corn Hypromelloses Mineral Oil Cellulose, Microcrystalline Titanium Dioxide Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: TCL011 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-18

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

• for the temporary relief of minor aches and pains due to

o headache

o colds

o muscle pain

o menstrual pain

o toothache

o minor pain of arthritis

• temporarily reduces fever

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 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:

o feel faint

o have bloody or black stools

o vomit blood

o 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

• you have lost a lot of fluid due to vomiting or diarrhea

Section 50570-1

Do not use if you have ever had an allergic to Aspirin or any other pain reliever/fever reducer

Section 51727-6

Inactive ingredients corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Section 51945-4

Section 53413-1

Questions? Call 1-800-824-1706 Monday – Friday 9am – 4pm MST

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

Purposes

Pain reliever/fever reducer





Section 55106-9

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug



Section 60561-8

Other information

• 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

• for the temporary relief of minor aches and pains due to

o headache

o colds

o muscle pain

o menstrual pain

o toothache

o minor pain of arthritis

• temporarily reduces fever

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 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:

o feel faint

o have bloody or black stools

o vomit blood

o 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

• you have lost a lot of fluid due to vomiting or diarrhea

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic to Aspirin or any other pain reliever/fever reducer

Section 51727-6 (51727-6)

Inactive ingredients corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-824-1706 Monday – Friday 9am – 4pm MST

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)

Purposes

Pain reliever/fever reducer





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

• 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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