Direct Safety Aspirin

Direct Safety Aspirin
SPL v7
SPL
SPL Set ID ba9ba697-d3df-49d7-e053-2a95a90af406
Route
ORAL
Published
Effective Date 2021-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Cellulose, Microcrystalline Povidone Starch, Corn Polyethylene Glycol, Unspecified Hypromellose, Unspecified Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: 44;157;ASPIRIN Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-02-15 Until 2024-04-01

Description

Drug Facts


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

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Indications and Usage

Uses

temporarily relieves

■ headache

■ muscle pain

■ toothache

■ menstrual pain

■ pain and fever of colds

■ minor pain of arthritis

Dosage and Administration

Directions

■ drink a full glass of water with each dose

Adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to

exceed 12 tablets in 24 hours

Children under 12 years: consult a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

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

■ 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 lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

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

Section 50570-1

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

Section 51727-6

I nactive ingredients

corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*

* may contain

Section 51945-4

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)

Section 53413-1

Questions or comments? 1-800-356-9100

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/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 room temperature

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves

■ headache

■ muscle pain

■ toothache

■ menstrual pain

■ pain and fever of colds

■ minor pain of arthritis

Dosage and Administration (34068-7)

Directions

■ drink a full glass of water with each dose

Adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to

exceed 12 tablets in 24 hours

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

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Section 42229-5 (42229-5)

Drug Facts

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

■ 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 lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

I nactive ingredients

corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*

* may contain

Section 51945-4 (51945-4)

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)

Section 53413-1 (53413-1)

Questions or comments? 1-800-356-9100

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/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 room temperature

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets


Advanced Ingredient Data


Raw Label Data

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