Gc 921

Gc 921
SPL v7
SPL
SPL Set ID bda805ab-7f37-405d-a144-4e06ad9a29a1
Route
ORAL
Published
Effective Date 2024-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Ferrosoferric Oxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Polyvinyl Acetate Phthalate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Propylene Glycol Shellac Silicon Dioxide Stearic Acid Sodium Bicarbonate Sodium Alginate Talc Titanium Dioxide Triacetin Triethyl Citrate Dimethicone

Identifiers & Packaging

Pill Appearance
Imprint: 44;227 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-07-01

Description

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

How Supplied

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug. NDC: 71335-0513-1: 30 Tablets in a BOTTLE NDC: 71335-0513-2: 60 Tablets in a BOTTLE NDC: 71335-0513-3: 100 Tablets in a BOTTLE NDC: 71335-0513-4: 90 Tablets in a BOTTLE NDC: 71335-0513-5: 20 Tablets in a BOTTLE NDC: 71335-0513-6: 45 Tablets in a BOTTLE NDC: 71335-0513-7: 120 Tablets in a BOTTLE NDC: 71335-0513-8: 7 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Pain reliever

How Supplied

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug.

NDC: 71335-0513-1: 30 Tablets in a BOTTLE

NDC: 71335-0513-2: 60 Tablets in a BOTTLE

NDC: 71335-0513-3: 100 Tablets in a BOTTLE

NDC: 71335-0513-4: 90 Tablets in a BOTTLE

NDC: 71335-0513-5: 20 Tablets in a BOTTLE

NDC: 71335-0513-6: 45 Tablets in a BOTTLE

NDC: 71335-0513-7: 120 Tablets in a BOTTLE

NDC: 71335-0513-8: 7 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin
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 51945-4

Aspirin E.C 325 mg Tablet

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

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

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • 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
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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 definitely directed to do so by a doctor because it may

cause problems in the unborn child or complications during delivery.

Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush

  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: do not use unless directed by a doctor
Other Information
  • store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
Inactive Ingredients

black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,

polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Tablet)

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin
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 51945-4 (51945-4)

Aspirin E.C 325 mg Tablet

Purpose

Pain reliever

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

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

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • 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
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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 definitely directed to do so by a doctor because it may

cause problems in the unborn child or complications during delivery.

Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush

  • do not exceed recommended dose
  • adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: do not use unless directed by a doctor
How Supplied (HOW SUPPLIED)

Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug.

NDC: 71335-0513-1: 30 Tablets in a BOTTLE

NDC: 71335-0513-2: 60 Tablets in a BOTTLE

NDC: 71335-0513-3: 100 Tablets in a BOTTLE

NDC: 71335-0513-4: 90 Tablets in a BOTTLE

NDC: 71335-0513-5: 20 Tablets in a BOTTLE

NDC: 71335-0513-6: 45 Tablets in a BOTTLE

NDC: 71335-0513-7: 120 Tablets in a BOTTLE

NDC: 71335-0513-8: 7 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)
  • store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
Inactive Ingredients (Inactive ingredients)

black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose,

polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)