Medifirst Aspirin

Medifirst Aspirin
SPL v10
SPL
SPL Set ID 2865a2c3-53fc-ab9a-e063-6394a90a1418
Route
ORAL
Published
Effective Date 2022-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Starch, Corn 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 Active Since 2020-07-20

Description

Active ingredient (in each tablet) Aspirin325 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

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

Dosage and Administration

Directions

  • drink a full glass of water with each dose

Adults and children:Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.

(12 years and over)

Children under 12 years:Consult a doctor

Description

Active ingredient (in each tablet) Aspirin325 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

  • 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
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms appear
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

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

Section 51727-6

Inactive ingredients

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

*m ay contain

Section 51945-4

Medique®

Aspirin

5 Grain (325 mg)

Pain Reliever/Fever Reducer

(NSAID)

This Package is for Households without Young Children.

Pull to Open

Aches/Fever • Aspirin 325 mg

200 Tablets (100 x 2)

Tamper Evident Unit Dose Packets

Section 53413-1

Questions or comments? 1-800-634-76870

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definately 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)

Aspirin325 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
Medi First Aspirin Label

100 Tablets

(50 x 2)

Medi-First®

Aspirin 5 Grain (325 mg)

Compare Acrive Ingredients to:

Genuine Bayer®

Registered Trademark of Pfizer Consumer

Pull To Open

Aches, Fever • Aspirin 325 mg

Pain Reliever/Fever Reducer (NSAID)

This Package is for Households without Young Children.

Tamper Evident Unit Dose Packets

Medi First Plus Aspirin Label

250 Tablets

(125 x 2's)

Medi First® Plus

Aspirin

This Package is for Households without Young Children.

Pull To Open

Aspirin 325 mg (NSAID)

Pain Reliever/Fever Reducer

Compare active ingredient to:

Genuine Bayer®

Registered Trademark of Bayer Corporation

Tamper Evident Unit Dose Packets

Medique Products Aspirin Label

Medique®

Aspirin

5 Grain (325 mg)

Pain Reliever/Fever Reducer

(NSAID)

This Package is for Households without Young Children.

Pull to Open

Aches/Fever • Aspirin 325 mg

200 Tablets (100 x 2)

Tamper Evident Unit Dose Packets


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves

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

Dosage and Administration (34068-7)

Directions

  • drink a full glass of water with each dose

Adults and children:Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.

(12 years and over)

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 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 gets worse or lasts more than 3 days
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms appear
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

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

Section 51727-6 (51727-6)

Inactive ingredients

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

*m ay contain

Section 51945-4 (51945-4)

Medique®

Aspirin

5 Grain (325 mg)

Pain Reliever/Fever Reducer

(NSAID)

This Package is for Households without Young Children.

Pull to Open

Aches/Fever • Aspirin 325 mg

200 Tablets (100 x 2)

Tamper Evident Unit Dose Packets

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-76870

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definately 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)

Aspirin325 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
Medi First Aspirin Label (Medi-First Aspirin Label)

100 Tablets

(50 x 2)

Medi-First®

Aspirin 5 Grain (325 mg)

Compare Acrive Ingredients to:

Genuine Bayer®

Registered Trademark of Pfizer Consumer

Pull To Open

Aches, Fever • Aspirin 325 mg

Pain Reliever/Fever Reducer (NSAID)

This Package is for Households without Young Children.

Tamper Evident Unit Dose Packets

Medi First Plus Aspirin Label (Medi-First Plus Aspirin Label)

250 Tablets

(125 x 2's)

Medi First® Plus

Aspirin

This Package is for Households without Young Children.

Pull To Open

Aspirin 325 mg (NSAID)

Pain Reliever/Fever Reducer

Compare active ingredient to:

Genuine Bayer®

Registered Trademark of Bayer Corporation

Tamper Evident Unit Dose Packets

Medique Products Aspirin Label

Medique®

Aspirin

5 Grain (325 mg)

Pain Reliever/Fever Reducer

(NSAID)

This Package is for Households without Young Children.

Pull to Open

Aches/Fever • Aspirin 325 mg

200 Tablets (100 x 2)

Tamper Evident Unit Dose Packets


Advanced Ingredient Data


Raw Label Data

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